HIV Infections
Conditions
Keywords
Drug Administration Schedule, Nucleoside Reverse Transcriptase Inhibitors, Pharmacokinetics
Brief summary
Pre-exposure prophylaxis (PrEP) is a method of preventing HIV infection through the use of antiretroviral (ARV) medications before exposure to HIV. This study will examine the feasibility of different methods of dosing for a PrEP regimen. Three methods of delivery will be compared: daily, time-based, and event-based.
Detailed description
No single strategy for the prevention of HIV has emerged as consistently used and successful, so multiple strategies have been developed. PrEP involves delivering ARV medications to people before they are exposed to HIV, in order to prevent infection. The optimal method of delivering PrEP has not yet been determined. This study will examine the feasibility of delivering PrEP in three methods. Daily dosing involves receiving ARV medications every day; time-driven dosing involves receiving ARV medications twice weekly plus a post-exposure dose; and event-driven dosing involves receiving ARV medications before and after a potential exposure to HIV. The ARV medication that will be used in this study is a combination pill that contains emtricitabine and tenofovir disoproxil fumarate (FTC/TDF). Recent research studies have shown that, if taken consistently, a daily oral dose of FTC/TDF can reduce the risk of HIV infection. This study will enroll HIV-uninfected men who have sex with men and transgender women (MSM/TGW) and women who have sex with men (WSM). Participation will last 34 weeks. All participants will be given a combination pill that contains FTC/TDF. For the first 5 weeks, all participants will come to the study clinic weekly to receive a single dose of FTC/TDF. At Week 6, participants will be randomly assigned to one of three groups. In the daily dosing group, participants will take FTC/TDF once a day. In the time-dosing group, participants will take FTC/TDF twice per week and another dose after sexual intercourse (a post-exposure dose). In the event-dosing group, participants will take FTC/TDF before and after sexual intercourse. During this part of the study, participants will be given FTC/TDF to take on their own. Every week, from Week 6 to Week 29, study officials will call to ask questions about how many pills participants have taken and when they have had sexual intercourse. Participants will also complete computer-assisted self-interviews (CASIs). Study visits will occur at enrollment, once a week for the first 5 weeks, and then once a month until Week 34. Assessment will include recording of medical history, completing an interview about sexual practices and background, and collection of blood, urine, and hair samples. Select study visits will include vaginal practices assessment (including use of lubricants and vaginal cleansing practices), family planning assessments (for women), and sex hormones assessments (for men). Participants who acquire HIV infection during the study will discontinue study product. These participants will continue to be followed after enrollment at Weeks 4, 6, 10, 14, 18, 22, 26, 30, and every 12 weeks thereafter, as appropriate, until the last study participant completes follow-up at the study site. Participants whose first reactive HIV rapid test is at Week 34 who are later confirmed to be HIV infected will also be followed every 12 weeks after their Week 30 visit until the last study participant completes follow-up at the study site. Participants who acquire HIV infection during the study will undergo select protocol procedures and will receive counseling and referrals for HIV treatment.
Interventions
DRUGDaily dosing
A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate.
TDF/FTC twice weekly with a post-exposure dose
DRUGEvent-driven dosing
TDF/FTC as needed with a post exposure dose
Sponsors
HIV Prevention Trials Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
One arm is daily TDF/FTC. One arm is twice weekly TDF/FTC with a post-exposure dose. One arm is as needed TDF/FTC with a post-exposure dose.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Literacy in one of the study languages (Thai, Xhosa, and/or English) * Able to provide written informed consent * Able to provide weekly telephonic updates * Within 70 days of enrollment: 1. Serum creatinine less than or equal to the upper limit of normal (ULN) and calculated creatinine clearance of at least 70 mL/min by the Cockcroft-Gault formula. More information on this criterion can be found in the protocol. 2. Serum phosphate greater than or equal to the lower limit of normal (LLN) 3. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 2 times ULN 4. Hemoglobin greater than 10 g/dL 5. Hepatitis B surface antigen (HBsAg)-negative 6. Willing and able to provide adequate locator information Inclusion Criteria for MSM/TGW: * Male at birth * Reporting anal intercourse and/or receptive neovaginal intercourse with at least one man or transgender woman in the past 6 months * One or more of the following risk factors for HIV acquisition in the past 6 months according to self-report: sexual intercourse with more than one man or transgender woman; history of an acute sexually transmitted infection (STI); sex in exchange for money, goods, or favors; condomless intercourse (oral, anal, vaginal, or neovaginal) with a partner known to be HIV-infected or of unknown HIV infection status according to self report Inclusion Criteria for Women Who Have Sex With Men (WSM): * Female at birth or self identify as female * Not pregnant or breastfeeding * Not able to or not intending to become pregnant during the next year * If able to become pregnant, self reported use of an effective method of contraception at Enrollment, and intending to use an effective method for the next 34 weeks * One or more of the following risk factors for HIV acquisition in the past 6 months according to self report: sexual intercourse with more than one man; history of an acute STI; sex in exchange for money, goods or favors; condomless intercourse (oral, anal, or vaginal) with a partner known to be HIV-infected or of unknown HIV infection status
Exclusion criteria
* Proteinuria 2+ or greater at screening * Glucosuria 2+ or greater at screening * Serious and active medical or mental illness * One or both HIV rapid tests is reactive at screening or enrollment, regardless of subsequent HIV diagnostic test results * Signs or symptoms suggestive of acute HIV infection * Use of hypoglycemic agents for diabetes or agents with known nephrotoxic potential * Use of ARV therapy (e.g., for post-exposure prophylaxis \[PEP\] or PrEP) in the 90 days prior to study entry * Serum phosphate level below site laboratory LLN * Current participation (or participation within 3 months of screening) in any HIV prevention study * Previous or current participation in the active arm of an HIV vaccine trial * Acute or chronic hepatitis B (HBV) infection (refers to chronic active HBV infection evidenced by a positive test for hepatitis B surface antigen (HBsAg) * Presence of a psychological or social condition or an addictive disorder that would preclude compliance with the protocol * Any other reason or condition that in the opinion of the investigator would interfere with participation, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Sexual Exposures Covered by Pre- and Post-exposure Dosing | From week 6 (randomization week) to week 30 (end of self-administered dosing) | Coverage will be determined based on the adjusted electronic and self-reported pill-use data. Specifically, a sex act will be considered as covered if at least one pill is taken 96 hours prior the sexual activity and at least one additional pill is taken within 24 hours after the sexual activity. If participant only took pill before the sexual activity (within 96 hours), but no pill taken after sexual activity (within 24 hours), then we considered it as pre-exposure covered. likewise, if participant only took pill after sexual activity (within 24 hours), but did not taken pill before sexual activity (within 96 hours), then we considered it as post-exposure covered. If participant did not taken pill before and after sexual activity, then it was considered as not covered. Note that the same pill can be both pre-exposure dose and a post-exposure dose if events are closely spaced. At no time should a participant in the intermittent arm be taking more pills than the daily arm. |
| The (Minimum) Total Number of Pills Needed for 100% Coverage Over the Follow-up Period (Based on Randomization Arm and Self-reported Sexual History in the Weekly Interviews) | From week 6 (randomization week) to week 30 (end of self-administered dosing) | Below I reported the number of sex acts as reported based on the adjusted electronic and self-reported sexual activity data, also the number of pills needed for 100% coverage. 100% coverage means all sex events (excluding oral sex) are covered; Note: sex act is considered as covered if at least one pill is taken 96 hours prior the sexual activity and at least one additional pill is taken within 24 hours after the sexual activity (same coverage definition for all three arms) |
| The Total Pills Actually Used Over the Follow-up Period | From week 6 (randomization week) to week 30 (end of self-administered dosing) | The total pills actually used over the follow-up period was calculated based on the adjusted electronic and self-reported pill-use data. It could be more or less than required by study design |
| Self-reported Side Effect or Symptom Scores | From week 6 (randomization week) to week 30 (end of self-administered dosing) | The self-reported symptom/side effect scores for common symptoms/side effects including headache, dizziness, cramping, abdominal pain, and flatulence. Collected during clinic visits. All the presented numbers are the percent of visits with each side effects |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of TFV-DP (Tenofovir Diphosphate) in PBMC (Peripheral Blood Mononuclear Cell) | week 10, 18 and 30, which is 4 weeks, 12 weeks, and 24 weeks after randomization | Below we presented the percentages of total cohort with TFV-DP concentrations consistent with \>=2 pills/week in women who also report sex in the last 7 day for each arm. For Cape Town and Bangkok, TFV-DP in PBMC was analyzed, for Harlem site, the TFV-DP in DBS (dried blood spot) was analyzed. Note: PBMC \>5.2 fmol/10\^6 cells is considered as participants taken \>=2 tablets per week; DBS \>=326 fmol/punch is considered as participants taken \>=2 tablets per week |
| The Proportion of Participants Who Discontinue All PrEP Use Based on Self-report Via CASI or Weekly Interviews | From Week 6 to Week 30 | — |
| A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | From week 6 (randomization week) to week 30 (end of self-administered dosing) | Only the listing of adverse events (AEs) by grade and arm are presented here. See outcome measure 10 for the listing of AE by relationship to study product |
| A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | From enrollment to week 30 (end of self-administered dosing) | Only the cross table between drug resistance by arm are presented here. See outcome measure 11 for the listing of plasma HIV RNA levels, and outcome measure 12 for the listing of drug resistance test by arm among all participants who seroconvert while on study. |
| The Percentage of Correctly Timed Adherence (Number of Pills Taken Within the Recommended Time Frame/Number of Pills Recommended) During 24 Weeks of Follow-up Based on Weekly Interviews and Adjusted EDM (Electronic Drug Monitoring) Data | From week 6 (randomization week) to week 30 (end of self-administered dosing) | — |
Countries
South Africa, Thailand, United States
Participant flow
Recruitment details
The study enrolled men, and transgender women, who have sex with men at a community clinic and clinical research site (CRS) in Bangkok, Thailand, and a CRS in Harlem in New York City, USA. Women were enrolled at a study site in Cape Town, South Africa. The last participant was enrolled in May of 2014
Pre-assignment details
Of the 902 screened participants, 622 were eligible to be enrolled into the study, and participated in a 6-week lead-in period of directly observed dosing (DOD) of one tablet once-weekly of FTC/TDF for five observed doses followed by 1-week off drug. 86% (N=536) completed the lead-in period and were randomized to the three arms.
Participants by arm
| Arm | Count |
|---|---|
| Daily Dosing, Cape Town Cape Town participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors. | 59 |
| Time-driven Dosing, Cape Town Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors. | 59 |
| Event-driven Dosing, Cape Town Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors. | 60 |
| Daily Dosing, Bangkok Bangkok participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors. | 60 |
| Time-driven Dosing, Bangkok Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors. | 59 |
| Event-driven Dosing, Bangkok Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors. | 59 |
| Daily Dosing, Harlem Harlem participants will receive oral FTC/TDF daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors. | 59 |
| Time-driven Dosing, Harlem Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors. | 60 |
| Event-driven Dosing, Harlem Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors. | 60 |
| Total | 535 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 |
|---|---|---|---|---|---|---|---|---|---|---|
| Post Study Follow-up | Lost to Follow-up | 0 | 1 | 1 | 0 | 0 | 0 | 4 | 1 | 2 |
| Self-administered Dosing Period | Ineligible (retrospective result) | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Self-administered Dosing Period | Lost to Follow-up | 3 | 2 | 4 | 2 | 3 | 0 | 8 | 9 | 10 |
| Self-administered Dosing Period | Withdrawal by Subject | 0 | 1 | 0 | 1 | 0 | 0 | 2 | 1 | 1 |
Baseline characteristics
| Characteristic | Daily Dosing, Bangkok | Time-driven Dosing, Bangkok | Daily Dosing, Cape Town | Time-driven Dosing, Cape Town | Event-driven Dosing, Cape Town | Event-driven Dosing, Bangkok | Daily Dosing, Harlem | Time-driven Dosing, Harlem | Event-driven Dosing, Harlem | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 31 years | 28 years | 25 years | 26 years | 25 years | 31 years | 28 years | 31 years | 32 years | 29 years |
| Age, Customized 18-24 years | 8 Participants | 12 Participants | 26 Participants | 24 Participants | 26 Participants | 8 Participants | 19 Participants | 17 Participants | 17 Participants | 157 Participants |
| Age, Customized 25-29 years | 13 Participants | 19 Participants | 14 Participants | 15 Participants | 8 Participants | 16 Participants | 13 Participants | 11 Participants | 8 Participants | 117 Participants |
| Age, Customized 30-39 years | 36 Participants | 23 Participants | 10 Participants | 11 Participants | 16 Participants | 28 Participants | 11 Participants | 12 Participants | 14 Participants | 161 Participants |
| Age, Customized 40+ years | 3 Participants | 5 Participants | 9 Participants | 9 Participants | 10 Participants | 7 Participants | 16 Participants | 20 Participants | 21 Participants | 100 Participants |
| Education Less than secondary | 0 Participants | 1 Participants | 38 Participants | 39 Participants | 39 Participants | 1 Participants | 16 Participants | 18 Participants | 7 Participants | 159 Participants |
| Education Secondary and above | 60 Participants | 58 Participants | 21 Participants | 20 Participants | 21 Participants | 58 Participants | 43 Participants | 42 Participants | 53 Participants | 376 Participants |
| Number of anal intercourse without a condom | 0 anal intercourse | 0 anal intercourse | 2 anal intercourse | 2 anal intercourse | 1 anal intercourse | 0 anal intercourse | 3 anal intercourse | 3 anal intercourse | 5 anal intercourse | 1 anal intercourse |
| Number of sex partners in the past 3 months | 3 sex partners | 3 sex partners | 1 sex partners | 1 sex partners | 1 sex partners | 3 sex partners | 3 sex partners | 3 sex partners | 4 sex partners | 2 sex partners |
| Sex/Gender, Customized Female | 0 Participants | 0 Participants | 59 Participants | 59 Participants | 60 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 178 Participants |
| Sex/Gender, Customized Gender queer | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Sex/Gender, Customized Male | 59 Participants | 58 Participants | 0 Participants | 0 Participants | 0 Participants | 59 Participants | 57 Participants | 59 Participants | 58 Participants | 350 Participants |
| Sex/Gender, Customized Transgender woman | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 59 / 59 | 59 / 59 | 59 / 60 | 58 / 60 | 59 / 59 | 58 / 59 | 53 / 59 | 55 / 60 | 54 / 60 |
| serious Total, serious adverse events | 1 / 59 | 0 / 59 | 2 / 60 | 5 / 60 | 1 / 59 | 3 / 59 | 3 / 59 | 6 / 60 | 1 / 60 |
Outcome results
Primary
Proportion of Sexual Exposures Covered by Pre- and Post-exposure Dosing
Coverage will be determined based on the adjusted electronic and self-reported pill-use data. Specifically, a sex act will be considered as covered if at least one pill is taken 96 hours prior the sexual activity and at least one additional pill is taken within 24 hours after the sexual activity. If participant only took pill before the sexual activity (within 96 hours), but no pill taken after sexual activity (within 24 hours), then we considered it as pre-exposure covered. likewise, if participant only took pill after sexual activity (within 24 hours), but did not taken pill before sexual activity (within 96 hours), then we considered it as post-exposure covered. If participant did not taken pill before and after sexual activity, then it was considered as not covered. Note that the same pill can be both pre-exposure dose and a post-exposure dose if events are closely spaced. At no time should a participant in the intermittent arm be taking more pills than the daily arm.
Time frame: From week 6 (randomization week) to week 30 (end of self-administered dosing)
Population: For Cape Town daily dosing arm, there are originally 60 participants, but 1 participant was later found to be HIV infected on or before randomization visit, which should make this participant not eligible for the study analysis, so we removed this participant from this table. Given this, we left 59 participants in Cape Town daily dosing arm
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Daily Dosing, Cape Town | Proportion of Sexual Exposures Covered by Pre- and Post-exposure Dosing | % post-exposure coverage | 1 percentage of sexual exposures |
| Daily Dosing, Cape Town | Proportion of Sexual Exposures Covered by Pre- and Post-exposure Dosing | % pre-exposure coverage | 21 percentage of sexual exposures |
| Daily Dosing, Cape Town | Proportion of Sexual Exposures Covered by Pre- and Post-exposure Dosing | % uncovered | 3 percentage of sexual exposures |
| Daily Dosing, Cape Town | Proportion of Sexual Exposures Covered by Pre- and Post-exposure Dosing | % completely covered | 75 percentage of sexual exposures |
| Time-driven Dosing, Cape Town | Proportion of Sexual Exposures Covered by Pre- and Post-exposure Dosing | % post-exposure coverage | 9 percentage of sexual exposures |
| Time-driven Dosing, Cape Town | Proportion of Sexual Exposures Covered by Pre- and Post-exposure Dosing | % completely covered | 56 percentage of sexual exposures |
| Time-driven Dosing, Cape Town | Proportion of Sexual Exposures Covered by Pre- and Post-exposure Dosing | % pre-exposure coverage | 30 percentage of sexual exposures |
| Time-driven Dosing, Cape Town | Proportion of Sexual Exposures Covered by Pre- and Post-exposure Dosing | % uncovered | 5 percentage of sexual exposures |
| Event-driven Dosing, Cape Town | Proportion of Sexual Exposures Covered by Pre- and Post-exposure Dosing | % completely covered | 52 percentage of sexual exposures |
| Event-driven Dosing, Cape Town | Proportion of Sexual Exposures Covered by Pre- and Post-exposure Dosing | % post-exposure coverage | 8 percentage of sexual exposures |
| Event-driven Dosing, Cape Town | Proportion of Sexual Exposures Covered by Pre- and Post-exposure Dosing | % uncovered | 7 percentage of sexual exposures |
| Event-driven Dosing, Cape Town | Proportion of Sexual Exposures Covered by Pre- and Post-exposure Dosing | % pre-exposure coverage | 33 percentage of sexual exposures |
| Daily Dosing, Bangkok | Proportion of Sexual Exposures Covered by Pre- and Post-exposure Dosing | % completely covered | 85 percentage of sexual exposures |
| Daily Dosing, Bangkok | Proportion of Sexual Exposures Covered by Pre- and Post-exposure Dosing | % uncovered | 3 percentage of sexual exposures |
| Daily Dosing, Bangkok | Proportion of Sexual Exposures Covered by Pre- and Post-exposure Dosing | % pre-exposure coverage | 11 percentage of sexual exposures |
| Daily Dosing, Bangkok | Proportion of Sexual Exposures Covered by Pre- and Post-exposure Dosing | % post-exposure coverage | 1 percentage of sexual exposures |
| Time-driven Dosing, Bangkok | Proportion of Sexual Exposures Covered by Pre- and Post-exposure Dosing | % completely covered | 84 percentage of sexual exposures |
| Time-driven Dosing, Bangkok | Proportion of Sexual Exposures Covered by Pre- and Post-exposure Dosing | % post-exposure coverage | 3 percentage of sexual exposures |
| Time-driven Dosing, Bangkok | Proportion of Sexual Exposures Covered by Pre- and Post-exposure Dosing | % uncovered | 1 percentage of sexual exposures |
| Time-driven Dosing, Bangkok | Proportion of Sexual Exposures Covered by Pre- and Post-exposure Dosing | % pre-exposure coverage | 12 percentage of sexual exposures |
| Event-driven Dosing, Bangkok | Proportion of Sexual Exposures Covered by Pre- and Post-exposure Dosing | % pre-exposure coverage | 19 percentage of sexual exposures |
| Event-driven Dosing, Bangkok | Proportion of Sexual Exposures Covered by Pre- and Post-exposure Dosing | % uncovered | 3 percentage of sexual exposures |
| Event-driven Dosing, Bangkok | Proportion of Sexual Exposures Covered by Pre- and Post-exposure Dosing | % post-exposure coverage | 5 percentage of sexual exposures |
| Event-driven Dosing, Bangkok | Proportion of Sexual Exposures Covered by Pre- and Post-exposure Dosing | % completely covered | 74 percentage of sexual exposures |
| Daily Dosing, Harlem | Proportion of Sexual Exposures Covered by Pre- and Post-exposure Dosing | % pre-exposure coverage | 24 percentage of sexual exposures |
| Daily Dosing, Harlem | Proportion of Sexual Exposures Covered by Pre- and Post-exposure Dosing | % completely covered | 66 percentage of sexual exposures |
| Daily Dosing, Harlem | Proportion of Sexual Exposures Covered by Pre- and Post-exposure Dosing | % post-exposure coverage | 2 percentage of sexual exposures |
| Daily Dosing, Harlem | Proportion of Sexual Exposures Covered by Pre- and Post-exposure Dosing | % uncovered | 8 percentage of sexual exposures |
| Time-driven Dosing, Harlem | Proportion of Sexual Exposures Covered by Pre- and Post-exposure Dosing | % completely covered | 47 percentage of sexual exposures |
| Time-driven Dosing, Harlem | Proportion of Sexual Exposures Covered by Pre- and Post-exposure Dosing | % post-exposure coverage | 8 percentage of sexual exposures |
| Time-driven Dosing, Harlem | Proportion of Sexual Exposures Covered by Pre- and Post-exposure Dosing | % pre-exposure coverage | 30 percentage of sexual exposures |
| Time-driven Dosing, Harlem | Proportion of Sexual Exposures Covered by Pre- and Post-exposure Dosing | % uncovered | 15 percentage of sexual exposures |
| Event-driven Dosing, Harlem | Proportion of Sexual Exposures Covered by Pre- and Post-exposure Dosing | % pre-exposure coverage | 29 percentage of sexual exposures |
| Event-driven Dosing, Harlem | Proportion of Sexual Exposures Covered by Pre- and Post-exposure Dosing | % completely covered | 52 percentage of sexual exposures |
| Event-driven Dosing, Harlem | Proportion of Sexual Exposures Covered by Pre- and Post-exposure Dosing | % uncovered | 13 percentage of sexual exposures |
| Event-driven Dosing, Harlem | Proportion of Sexual Exposures Covered by Pre- and Post-exposure Dosing | % post-exposure coverage | 6 percentage of sexual exposures |
Primary
Self-reported Side Effect or Symptom Scores
The self-reported symptom/side effect scores for common symptoms/side effects including headache, dizziness, cramping, abdominal pain, and flatulence. Collected during clinic visits. All the presented numbers are the percent of visits with each side effects
Time frame: From week 6 (randomization week) to week 30 (end of self-administered dosing)
Population: For Cape Town daily dosing arm, there are originally 60 participants, but 1 participant was later found to be HIV infected on or before randomization visit, which should make this participant not eligible for the study analysis, so we removed this participant from this table. Given this, we left 59 participants in Cape Town daily dosing arm
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Daily Dosing, Cape Town | Self-reported Side Effect or Symptom Scores | Neurologic side effect | 12.4 percent of visits between week 6 to 30 |
| Daily Dosing, Cape Town | Self-reported Side Effect or Symptom Scores | Gastrointestinal side effects | 10.6 percent of visits between week 6 to 30 |
| Time-driven Dosing, Cape Town | Self-reported Side Effect or Symptom Scores | Neurologic side effect | 6.0 percent of visits between week 6 to 30 |
| Time-driven Dosing, Cape Town | Self-reported Side Effect or Symptom Scores | Gastrointestinal side effects | 8.8 percent of visits between week 6 to 30 |
| Event-driven Dosing, Cape Town | Self-reported Side Effect or Symptom Scores | Neurologic side effect | 7.8 percent of visits between week 6 to 30 |
| Event-driven Dosing, Cape Town | Self-reported Side Effect or Symptom Scores | Gastrointestinal side effects | 5.4 percent of visits between week 6 to 30 |
| Daily Dosing, Bangkok | Self-reported Side Effect or Symptom Scores | Neurologic side effect | 14.2 percent of visits between week 6 to 30 |
| Daily Dosing, Bangkok | Self-reported Side Effect or Symptom Scores | Gastrointestinal side effects | 13.1 percent of visits between week 6 to 30 |
| Time-driven Dosing, Bangkok | Self-reported Side Effect or Symptom Scores | Neurologic side effect | 14.3 percent of visits between week 6 to 30 |
| Time-driven Dosing, Bangkok | Self-reported Side Effect or Symptom Scores | Gastrointestinal side effects | 8.5 percent of visits between week 6 to 30 |
| Event-driven Dosing, Bangkok | Self-reported Side Effect or Symptom Scores | Gastrointestinal side effects | 10.5 percent of visits between week 6 to 30 |
| Event-driven Dosing, Bangkok | Self-reported Side Effect or Symptom Scores | Neurologic side effect | 13.3 percent of visits between week 6 to 30 |
| Daily Dosing, Harlem | Self-reported Side Effect or Symptom Scores | Gastrointestinal side effects | 8 percent of visits between week 6 to 30 |
| Daily Dosing, Harlem | Self-reported Side Effect or Symptom Scores | Neurologic side effect | 6.1 percent of visits between week 6 to 30 |
| Time-driven Dosing, Harlem | Self-reported Side Effect or Symptom Scores | Neurologic side effect | 3.3 percent of visits between week 6 to 30 |
| Time-driven Dosing, Harlem | Self-reported Side Effect or Symptom Scores | Gastrointestinal side effects | 5.8 percent of visits between week 6 to 30 |
| Event-driven Dosing, Harlem | Self-reported Side Effect or Symptom Scores | Neurologic side effect | 4.5 percent of visits between week 6 to 30 |
| Event-driven Dosing, Harlem | Self-reported Side Effect or Symptom Scores | Gastrointestinal side effects | 7.1 percent of visits between week 6 to 30 |
Primary
The (Minimum) Total Number of Pills Needed for 100% Coverage Over the Follow-up Period (Based on Randomization Arm and Self-reported Sexual History in the Weekly Interviews)
Below I reported the number of sex acts as reported based on the adjusted electronic and self-reported sexual activity data, also the number of pills needed for 100% coverage. 100% coverage means all sex events (excluding oral sex) are covered; Note: sex act is considered as covered if at least one pill is taken 96 hours prior the sexual activity and at least one additional pill is taken within 24 hours after the sexual activity (same coverage definition for all three arms)
Time frame: From week 6 (randomization week) to week 30 (end of self-administered dosing)
Population: For Cape Town daily dosing arm, there are originally 60 participants, but 1 participant was later found to be HIV infected on or before randomization visit, which should make this participant not eligible for the study analysis, so we removed this participant from this table. Given this, we left 59 participants in Cape Town daily dosing arm
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Daily Dosing, Cape Town | The (Minimum) Total Number of Pills Needed for 100% Coverage Over the Follow-up Period (Based on Randomization Arm and Self-reported Sexual History in the Weekly Interviews) | 2097 Number of pills needed for 100% coverage |
| Time-driven Dosing, Cape Town | The (Minimum) Total Number of Pills Needed for 100% Coverage Over the Follow-up Period (Based on Randomization Arm and Self-reported Sexual History in the Weekly Interviews) | 1552 Number of pills needed for 100% coverage |
| Event-driven Dosing, Cape Town | The (Minimum) Total Number of Pills Needed for 100% Coverage Over the Follow-up Period (Based on Randomization Arm and Self-reported Sexual History in the Weekly Interviews) | 1906 Number of pills needed for 100% coverage |
| Daily Dosing, Bangkok | The (Minimum) Total Number of Pills Needed for 100% Coverage Over the Follow-up Period (Based on Randomization Arm and Self-reported Sexual History in the Weekly Interviews) | 1746 Number of pills needed for 100% coverage |
| Time-driven Dosing, Bangkok | The (Minimum) Total Number of Pills Needed for 100% Coverage Over the Follow-up Period (Based on Randomization Arm and Self-reported Sexual History in the Weekly Interviews) | 1573 Number of pills needed for 100% coverage |
| Event-driven Dosing, Bangkok | The (Minimum) Total Number of Pills Needed for 100% Coverage Over the Follow-up Period (Based on Randomization Arm and Self-reported Sexual History in the Weekly Interviews) | 1268 Number of pills needed for 100% coverage |
| Daily Dosing, Harlem | The (Minimum) Total Number of Pills Needed for 100% Coverage Over the Follow-up Period (Based on Randomization Arm and Self-reported Sexual History in the Weekly Interviews) | 1244 Number of pills needed for 100% coverage |
| Time-driven Dosing, Harlem | The (Minimum) Total Number of Pills Needed for 100% Coverage Over the Follow-up Period (Based on Randomization Arm and Self-reported Sexual History in the Weekly Interviews) | 1390 Number of pills needed for 100% coverage |
| Event-driven Dosing, Harlem | The (Minimum) Total Number of Pills Needed for 100% Coverage Over the Follow-up Period (Based on Randomization Arm and Self-reported Sexual History in the Weekly Interviews) | 1582 Number of pills needed for 100% coverage |
Primary
The Total Pills Actually Used Over the Follow-up Period
The total pills actually used over the follow-up period was calculated based on the adjusted electronic and self-reported pill-use data. It could be more or less than required by study design
Time frame: From week 6 (randomization week) to week 30 (end of self-administered dosing)
Population: For Cape Town daily dosing arm, there are originally 60 participants, but 1 participant was later found to be HIV infected on or before randomization visit, which should make this participant not eligible for the study analysis, so we removed this participant from this table. Given this, we left 59 participants in Cape Town daily dosing arm
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Daily Dosing, Cape Town | The Total Pills Actually Used Over the Follow-up Period | 7349 Number of pills actually used |
| Time-driven Dosing, Cape Town | The Total Pills Actually Used Over the Follow-up Period | 2852 Number of pills actually used |
| Event-driven Dosing, Cape Town | The Total Pills Actually Used Over the Follow-up Period | 2000 Number of pills actually used |
| Daily Dosing, Bangkok | The Total Pills Actually Used Over the Follow-up Period | 8285 Number of pills actually used |
| Time-driven Dosing, Bangkok | The Total Pills Actually Used Over the Follow-up Period | 3713 Number of pills actually used |
| Event-driven Dosing, Bangkok | The Total Pills Actually Used Over the Follow-up Period | 2157 Number of pills actually used |
| Daily Dosing, Harlem | The Total Pills Actually Used Over the Follow-up Period | 5507 Number of pills actually used |
| Time-driven Dosing, Harlem | The Total Pills Actually Used Over the Follow-up Period | 2468 Number of pills actually used |
| Event-driven Dosing, Harlem | The Total Pills Actually Used Over the Follow-up Period | 2356 Number of pills actually used |
Secondary
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Only the listing of drug resistance test by arm among all participants who seroconvert while on study are presented here. See outcome measure 11 for the listing of plasma HIV RNA levels
Time frame: From Enrollment to week 30 (end of self-administered dosing)
Population: Below, each seroconverted participants' drug resistance test availability was presented. If the number analyzed equal to 0 then it means the resistance test was not done. When the number analyzed equal to 1 and outcome value is 0 then it means no drug resistance was detected, but if the outcome value is 1 then it means drug resistance was detected.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Daily Dosing, Cape Town | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Enrollment | 0 viral load |
| Daily Dosing, Cape Town | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 4 | 1 viral load |
| Time-driven Dosing, Cape Town | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Enrollment | 0 viral load |
| Time-driven Dosing, Cape Town | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 5 | 0 viral load |
| Time-driven Dosing, Cape Town | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 6 | 0 viral load |
| Time-driven Dosing, Cape Town | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 4 | 0 viral load |
| Event-driven Dosing, Cape Town | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 6 | 0 viral load |
| Event-driven Dosing, Cape Town | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 14 | 0 viral load |
| Event-driven Dosing, Cape Town | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 18 | 0 viral load |
| Event-driven Dosing, Cape Town | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 26 | 0 viral load |
| Event-driven Dosing, Cape Town | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 5 | 0 viral load |
| Event-driven Dosing, Cape Town | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 4 | 0 viral load |
| Event-driven Dosing, Cape Town | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 22 | 0 viral load |
| Event-driven Dosing, Cape Town | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 10 | 0 viral load |
| Event-driven Dosing, Cape Town | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Enrollment | 0 viral load |
| Daily Dosing, Bangkok | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 18 | 0 viral load |
| Daily Dosing, Bangkok | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 10 | 0 viral load |
| Daily Dosing, Bangkok | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 4 | 0 viral load |
| Daily Dosing, Bangkok | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 5 | 0 viral load |
| Daily Dosing, Bangkok | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 6 | 0 viral load |
| Daily Dosing, Bangkok | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 14 | 0 viral load |
| Daily Dosing, Bangkok | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Enrollment | 0 viral load |
| Daily Dosing, Bangkok | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 22 | 0 viral load |
| Time-driven Dosing, Bangkok | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 18 | 0 viral load |
| Time-driven Dosing, Bangkok | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 14 | 0 viral load |
| Time-driven Dosing, Bangkok | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 5 | 0 viral load |
| Time-driven Dosing, Bangkok | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 22 | 0 viral load |
| Time-driven Dosing, Bangkok | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 10 | 0 viral load |
| Time-driven Dosing, Bangkok | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 4 | 0 viral load |
| Time-driven Dosing, Bangkok | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 6 | 0 viral load |
| Time-driven Dosing, Bangkok | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Enrollment | 0 viral load |
| Event-driven Dosing, Bangkok | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 4 | 0 viral load |
| Event-driven Dosing, Bangkok | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 6 | 0 viral load |
| Event-driven Dosing, Bangkok | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 18 | 1 viral load |
| Event-driven Dosing, Bangkok | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Enrollment | 0 viral load |
| Event-driven Dosing, Bangkok | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 14 | 0 viral load |
| Event-driven Dosing, Bangkok | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 10 | 0 viral load |
| Event-driven Dosing, Bangkok | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 5 | 0 viral load |
| Daily Dosing, Harlem | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 10 | 0 viral load |
| Daily Dosing, Harlem | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 22 | 0 viral load |
| Daily Dosing, Harlem | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 18 | 0 viral load |
| Daily Dosing, Harlem | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 5 | 0 viral load |
| Daily Dosing, Harlem | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 6 | 0 viral load |
| Daily Dosing, Harlem | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Enrollment | 0 viral load |
| Daily Dosing, Harlem | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 14 | 0 viral load |
| Daily Dosing, Harlem | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 4 | 0 viral load |
| Time-driven Dosing, Harlem | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 30 | 0 viral load |
| Time-driven Dosing, Harlem | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 5 | 0 viral load |
| Time-driven Dosing, Harlem | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 6 | 0 viral load |
| Time-driven Dosing, Harlem | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 18 | 0 viral load |
| Time-driven Dosing, Harlem | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 22 | 0 viral load |
| Time-driven Dosing, Harlem | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Enrollment | 0 viral load |
| Time-driven Dosing, Harlem | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 4 | 0 viral load |
| Time-driven Dosing, Harlem | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 10 | 0 viral load |
| Time-driven Dosing, Harlem | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 14 | 0 viral load |
| Time-driven Dosing, Harlem | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 26 | 0 viral load |
| Event-driven Dosing, Harlem | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 6 | 0 viral load |
| Event-driven Dosing, Harlem | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Enrollment | 0 viral load |
| Event-driven Dosing, Harlem | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 4 | 0 viral load |
| Bangkok, Thailand, Seroconverted Participant #2 | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Enrollment | 0 viral load |
| Bangkok, Thailand, Seroconverted Participant #2 | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 4 | 0 viral load |
| Bangkok, Thailand, Seroconverted Participant #2 | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 5 | 0 viral load |
| Harlem, United States, Seroconverted Participant #1 | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 4 | 1 viral load |
| Harlem, United States, Seroconverted Participant #1 | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Enrollment | 0 viral load |
| Harlem, United States, Seroconverted Participant #2 | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 14 | 0 viral load |
| Harlem, United States, Seroconverted Participant #2 | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 18 | 0 viral load |
| Harlem, United States, Seroconverted Participant #2 | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 4 | 0 viral load |
| Harlem, United States, Seroconverted Participant #2 | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Enrollment | 0 viral load |
| Harlem, United States, Seroconverted Participant #2 | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 6 | 0 viral load |
| Harlem, United States, Seroconverted Participant #2 | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 5 | 0 viral load |
| Harlem, United States, Seroconverted Participant #2 | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 10 | 0 viral load |
Secondary
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Only the cross table between drug resistance by arm are presented here. See outcome measure 11 for the listing of plasma HIV RNA levels, and outcome measure 12 for the listing of drug resistance test by arm among all participants who seroconvert while on study.
Time frame: From enrollment to week 30 (end of self-administered dosing)
Population: Data is collected for plasma HIV RNA levels among all participants who seroconvert while on study, but this secondary analysis has not been carried out yet, so no outcome measure is presented here
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Daily Dosing, Cape Town | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | After Randomization (Time-driven dosing) | No Drug Resistance | 58 Participants |
| Daily Dosing, Cape Town | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | After Randomization (Daily dosing) | Drug Resistance | 0 Participants |
| Daily Dosing, Cape Town | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | After Randomization (Event-driven dosing) | No Drug Resistance | 60 Participants |
| Daily Dosing, Cape Town | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | After Randomization (Event-driven dosing) | Drug Resistance | 0 Participants |
| Daily Dosing, Cape Town | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Before Randomization | No Drug Resistance | 190 Participants |
| Daily Dosing, Cape Town | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | After Randomization (Time-driven dosing) | Drug Resistance | 1 Participants |
| Daily Dosing, Cape Town | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | After Randomization (Daily dosing) | No Drug Resistance | 59 Participants |
| Daily Dosing, Cape Town | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Before Randomization | Drug Resistance | 1 Participants |
| Time-driven Dosing, Cape Town | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | After Randomization (Event-driven dosing) | Drug Resistance | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Before Randomization | No Drug Resistance | 193 Participants |
| Time-driven Dosing, Cape Town | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | After Randomization (Daily dosing) | No Drug Resistance | 60 Participants |
| Time-driven Dosing, Cape Town | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | After Randomization (Time-driven dosing) | Drug Resistance | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | After Randomization (Time-driven dosing) | No Drug Resistance | 59 Participants |
| Time-driven Dosing, Cape Town | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | After Randomization (Event-driven dosing) | No Drug Resistance | 59 Participants |
| Time-driven Dosing, Cape Town | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Before Randomization | Drug Resistance | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | After Randomization (Daily dosing) | Drug Resistance | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | After Randomization (Event-driven dosing) | No Drug Resistance | 60 Participants |
| Event-driven Dosing, Cape Town | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | After Randomization (Time-driven dosing) | Drug Resistance | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | After Randomization (Daily dosing) | Drug Resistance | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Before Randomization | Drug Resistance | 1 Participants |
| Event-driven Dosing, Cape Town | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Before Randomization | No Drug Resistance | 237 Participants |
| Event-driven Dosing, Cape Town | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | After Randomization (Event-driven dosing) | Drug Resistance | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | After Randomization (Time-driven dosing) | No Drug Resistance | 60 Participants |
| Event-driven Dosing, Cape Town | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | After Randomization (Daily dosing) | No Drug Resistance | 59 Participants |
Secondary
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Only the listing of plasma HIV RNA levels among all participants who seroconvert while on study are presented here. See outcome measure 12 for the listing of drug resistance test by arm.
Time frame: From Enrollment to week 30 (end of self-administered dosing)
Population: Below, each seroconverted participants' plasma HIV RNA levels at all visits with test results are presented
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Daily Dosing, Cape Town | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 5 | 5732050 viral load |
| Daily Dosing, Cape Town | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 10 | 416070 viral load |
| Daily Dosing, Cape Town | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Enrollment | 20 viral load |
| Daily Dosing, Cape Town | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 4 | 3460 viral load |
| Daily Dosing, Cape Town | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Day 3 | 400 viral load |
| Time-driven Dosing, Cape Town | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 30 | 35210 viral load |
| Time-driven Dosing, Cape Town | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 14 | 93660 viral load |
| Time-driven Dosing, Cape Town | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 18 | 114520 viral load |
| Time-driven Dosing, Cape Town | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 5 | 3938670 viral load |
| Time-driven Dosing, Cape Town | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 26 | 89970 viral load |
| Time-driven Dosing, Cape Town | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 10 | 93040 viral load |
| Time-driven Dosing, Cape Town | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 4 | 3667690 viral load |
| Time-driven Dosing, Cape Town | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 22 | 178210 viral load |
| Time-driven Dosing, Cape Town | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Day 3 | 400 viral load |
| Event-driven Dosing, Cape Town | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 26 | 503950 viral load |
| Event-driven Dosing, Cape Town | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 30 | 10910 viral load |
| Daily Dosing, Bangkok | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 18 | 650 viral load |
| Daily Dosing, Bangkok | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 6 | 400 viral load |
| Daily Dosing, Bangkok | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 22 | 400 viral load |
| Daily Dosing, Bangkok | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 14 | 400 viral load |
| Daily Dosing, Bangkok | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 10 | 400 viral load |
| Time-driven Dosing, Bangkok | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 22 | 5887760 viral load |
| Event-driven Dosing, Bangkok | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 22 | 127480 viral load |
| Event-driven Dosing, Bangkok | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 26 | 220830 viral load |
| Event-driven Dosing, Bangkok | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 18 | 3710 viral load |
| Event-driven Dosing, Bangkok | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 14 | 2100 viral load |
| Event-driven Dosing, Bangkok | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 30 | 193130 viral load |
| Daily Dosing, Harlem | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 22 | 136310 viral load |
| Daily Dosing, Harlem | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 18 | 83010 viral load |
| Daily Dosing, Harlem | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 26 | 25020 viral load |
| Daily Dosing, Harlem | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 30 | 29390 viral load |
| Time-driven Dosing, Harlem | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 26 | 400 viral load |
| Time-driven Dosing, Harlem | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 30 | 400 viral load |
| Event-driven Dosing, Harlem | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 4 | 749590 viral load |
| Event-driven Dosing, Harlem | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Day 3 | 40 viral load |
| Event-driven Dosing, Harlem | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 30 | 36140 viral load |
| Event-driven Dosing, Harlem | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 22 | 178070 viral load |
| Event-driven Dosing, Harlem | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 18 | 127330 viral load |
| Event-driven Dosing, Harlem | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 10 | 1799950 viral load |
| Event-driven Dosing, Harlem | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 14 | 119720 viral load |
| Event-driven Dosing, Harlem | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 6 | 92960 viral load |
| Event-driven Dosing, Harlem | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 26 | 96180 viral load |
| Bangkok, Thailand, Seroconverted Participant #2 | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Day 3 | 78450 viral load |
| Bangkok, Thailand, Seroconverted Participant #2 | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 4 | 710 viral load |
| Bangkok, Thailand, Seroconverted Participant #2 | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 5 | 1570 viral load |
| Bangkok, Thailand, Seroconverted Participant #2 | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 6 | 5070 viral load |
| Harlem, United States, Seroconverted Participant #1 | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 6 | 83260 viral load |
| Harlem, United States, Seroconverted Participant #1 | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Day 3 | 400 viral load |
| Harlem, United States, Seroconverted Participant #1 | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 4 | 40900 viral load |
| Harlem, United States, Seroconverted Participant #2 | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 18 | 73030 viral load |
| Harlem, United States, Seroconverted Participant #2 | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study | Week 14 | 1567040 viral load |
Secondary
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Only the listing of AE related to study product are presented here. See outcome measure 6 for the listing of adverse events (AEs) by grade and arm.
Time frame: From week 6 (randomization week) to week 30 (end of self-administered dosing)
Population: Below Number analyzed population only included the participants who had below adverse events, and the number next to it represent the number of participants had the corresponding AE that was related to the study product
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Injury, poisoning and procedural complications | 3 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Ear and labyrinth disorders | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Cardiac disorders | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Gastrointestinal disorders | 18 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Neoplasms benign, malignant, and unspecified | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Blood and lymphatic system disorders | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Metabolism and nutrition disorders | 2 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Renal and urinary disorders | 10 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Eye disorders | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Pregnancy, puerperium and perinatal conditions | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Infections and infestations | 1 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Vascular disorders | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | General disorders and administration site conditio | 4 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Respiratory, thoracic and mediastinal disorders | 2 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Reproductive system and breast disorders | 1 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Hepatobiliary disorders | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Skin and subcutaneous tissue disorders | 4 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Psychiatric disorders | 3 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Immune system disorders | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Social circumstances | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Nervous system disorders | 17 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Musculoskeletal and connective tissue disorders | 1 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Investigations | 10 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Investigations | 13 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Cardiac disorders | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Respiratory, thoracic and mediastinal disorders | 1 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Infections and infestations | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Injury, poisoning and procedural complications | 4 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Metabolism and nutrition disorders | 5 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Nervous system disorders | 17 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Blood and lymphatic system disorders | 2 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Social circumstances | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Musculoskeletal and connective tissue disorders | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Skin and subcutaneous tissue disorders | 5 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Eye disorders | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Neoplasms benign, malignant, and unspecified | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Psychiatric disorders | 1 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Ear and labyrinth disorders | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Gastrointestinal disorders | 17 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Renal and urinary disorders | 5 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Pregnancy, puerperium and perinatal conditions | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Vascular disorders | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | General disorders and administration site conditio | 1 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Hepatobiliary disorders | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Reproductive system and breast disorders | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Immune system disorders | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Renal and urinary disorders | 10 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Metabolism and nutrition disorders | 6 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Musculoskeletal and connective tissue disorders | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Eye disorders | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Vascular disorders | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Gastrointestinal disorders | 24 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Immune system disorders | 1 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Infections and infestations | 2 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Cardiac disorders | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Investigations | 12 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Reproductive system and breast disorders | 1 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Pregnancy, puerperium and perinatal conditions | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Psychiatric disorders | 1 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Injury, poisoning and procedural complications | 7 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Respiratory, thoracic and mediastinal disorders | 2 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Skin and subcutaneous tissue disorders | 3 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Ear and labyrinth disorders | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Social circumstances | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Nervous system disorders | 21 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | General disorders and administration site conditio | 6 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Neoplasms benign, malignant, and unspecified | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Hepatobiliary disorders | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Blood and lymphatic system disorders | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Respiratory, thoracic and mediastinal disorders | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Blood and lymphatic system disorders | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Social circumstances | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Reproductive system and breast disorders | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Eye disorders | 1 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Musculoskeletal and connective tissue disorders | 2 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Hepatobiliary disorders | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Skin and subcutaneous tissue disorders | 2 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Cardiac disorders | 1 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Metabolism and nutrition disorders | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Pregnancy, puerperium and perinatal conditions | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | General disorders and administration site conditio | 1 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Ear and labyrinth disorders | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Psychiatric disorders | 1 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Injury, poisoning and procedural complications | 10 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Infections and infestations | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Gastrointestinal disorders | 9 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Investigations | 23 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Renal and urinary disorders | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Neoplasms benign, malignant, and unspecified | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Nervous system disorders | 3 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Immune system disorders | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Vascular disorders | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | General disorders and administration site conditio | 1 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Psychiatric disorders | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Blood and lymphatic system disorders | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Pregnancy, puerperium and perinatal conditions | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Gastrointestinal disorders | 1 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Renal and urinary disorders | 1 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Vascular disorders | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Eye disorders | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Skin and subcutaneous tissue disorders | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Hepatobiliary disorders | 1 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Nervous system disorders | 2 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Social circumstances | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Metabolism and nutrition disorders | 1 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Musculoskeletal and connective tissue disorders | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Ear and labyrinth disorders | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Neoplasms benign, malignant, and unspecified | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Infections and infestations | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Investigations | 12 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Injury, poisoning and procedural complications | 7 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Cardiac disorders | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Respiratory, thoracic and mediastinal disorders | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Immune system disorders | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Reproductive system and breast disorders | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Pregnancy, puerperium and perinatal conditions | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | General disorders and administration site conditio | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Injury, poisoning and procedural complications | 10 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Investigations | 10 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Gastrointestinal disorders | 2 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Respiratory, thoracic and mediastinal disorders | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Neoplasms benign, malignant, and unspecified | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Psychiatric disorders | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Reproductive system and breast disorders | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Skin and subcutaneous tissue disorders | 2 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Infections and infestations | 1 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Nervous system disorders | 1 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Immune system disorders | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Vascular disorders | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Metabolism and nutrition disorders | 1 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Hepatobiliary disorders | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Eye disorders | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Social circumstances | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Musculoskeletal and connective tissue disorders | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Renal and urinary disorders | 2 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Ear and labyrinth disorders | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Cardiac disorders | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Blood and lymphatic system disorders | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Vascular disorders | 1 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Ear and labyrinth disorders | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Eye disorders | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Gastrointestinal disorders | 13 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Immune system disorders | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Infections and infestations | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Injury, poisoning and procedural complications | 13 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Neoplasms benign, malignant, and unspecified | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Renal and urinary disorders | 8 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Respiratory, thoracic and mediastinal disorders | 2 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Skin and subcutaneous tissue disorders | 1 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Blood and lymphatic system disorders | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Cardiac disorders | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | General disorders and administration site conditio | 3 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Hepatobiliary disorders | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Investigations | 9 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Metabolism and nutrition disorders | 4 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Musculoskeletal and connective tissue disorders | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Nervous system disorders | 7 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Pregnancy, puerperium and perinatal conditions | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Psychiatric disorders | 2 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Reproductive system and breast disorders | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Social circumstances | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Gastrointestinal disorders | 13 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | General disorders and administration site conditio | 9 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Cardiac disorders | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Blood and lymphatic system disorders | 2 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Vascular disorders | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Skin and subcutaneous tissue disorders | 2 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Hepatobiliary disorders | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Pregnancy, puerperium and perinatal conditions | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Respiratory, thoracic and mediastinal disorders | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Psychiatric disorders | 2 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Nervous system disorders | 4 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Eye disorders | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Renal and urinary disorders | 9 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Neoplasms benign, malignant, and unspecified | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Metabolism and nutrition disorders | 5 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Reproductive system and breast disorders | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Injury, poisoning and procedural complications | 16 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Immune system disorders | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Ear and labyrinth disorders | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Social circumstances | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Investigations | 9 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Musculoskeletal and connective tissue disorders | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Infections and infestations | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Neoplasms benign, malignant, and unspecified | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | General disorders and administration site conditio | 4 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Cardiac disorders | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Metabolism and nutrition disorders | 5 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Blood and lymphatic system disorders | 1 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Infections and infestations | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Vascular disorders | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Investigations | 7 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Skin and subcutaneous tissue disorders | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Injury, poisoning and procedural complications | 10 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Ear and labyrinth disorders | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Eye disorders | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Gastrointestinal disorders | 16 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Pregnancy, puerperium and perinatal conditions | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Respiratory, thoracic and mediastinal disorders | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Reproductive system and breast disorders | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Psychiatric disorders | 3 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Social circumstances | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Nervous system disorders | 5 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Immune system disorders | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Musculoskeletal and connective tissue disorders | 3 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Hepatobiliary disorders | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Renal and urinary disorders | 4 Participants |
Secondary
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Only the listing of adverse events (AEs) by grade and arm are presented here. See outcome measure 10 for the listing of AE by relationship to study product
Time frame: From week 6 (randomization week) to week 30 (end of self-administered dosing)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Psychiatric disorders | Moderate | 2 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Vascular disorders | Mild | 2 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Pregnancy, puerperium and perinatal conditions | Death | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | General disorders and administration site conditio | Moderate | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Pregnancy, puerperium and perinatal conditions | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Social circumstances | None | 58 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Eye disorders | Moderate | 2 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | General disorders and administration site conditio | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Hepatobiliary disorders | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Pregnancy, puerperium and perinatal conditions | Severe | 1 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Ear and labyrinth disorders | Mild | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Nervous system disorders | None | 27 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Blood and lymphatic system disorders : Mild | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Nervous system disorders | Death | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Immune system disorders | Moderate | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Eye disorders | Severe | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Cardiac disorders | Death | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Investigations | Moderate | 5 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Nervous system disorders | Moderate | 15 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Skin and subcutaneous tissue disorders | Moderate | 3 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Hepatobiliary disorders | Severe | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Musculoskeletal and connective tissue disorders | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Reproductive system and breast disorders | None | 39 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Musculoskeletal and connective tissue disorders | Mild | 6 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Eye disorders | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Gastrointestinal disorders | Moderate | 8 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Injury, poisoning and procedural complications | Mild | 7 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Reproductive system and breast disorders | Death | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Metabolism and nutrition disorders | None | 50 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Ear and labyrinth disorders | Moderate | 1 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Metabolism and nutrition disorders | Severe | 3 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Blood and lymphatic system disorders : Mild | Severe | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Social circumstances | Death | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Eye disorders | Death | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Neoplasms benign, malignant, and unspecified | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Reproductive system and breast disorders | Moderate | 7 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Investigations | None | 41 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | General disorders and administration site conditio | Severe | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Investigations | Death | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Reproductive system and breast disorders | Mild | 13 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Investigations | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Neoplasms benign, malignant, and unspecified | Moderate | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Eye disorders | None | 55 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Renal and urinary disorders | Severe | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Cardiac disorders | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Injury, poisoning and procedural complications | None | 48 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Ear and labyrinth disorders | Severe | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Injury, poisoning and procedural complications | Death | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Hepatobiliary disorders | None | 59 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Injury, poisoning and procedural complications | Severe | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Reproductive system and breast disorders | Severe | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Gastrointestinal disorders | Mild | 18 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Vascular disorders | Moderate | 1 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Renal and urinary disorders | Moderate | 4 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Injury, poisoning and procedural complications | Moderate | 3 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Cardiac disorders | None | 59 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Infections and infestations | Death | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Psychiatric disorders | Potentically Life Threatening | 1 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Infections and infestations | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Blood and lymphatic system disorders : Mild | Death | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Gastrointestinal disorders | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Psychiatric disorders | Severe | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Ear and labyrinth disorders | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Infections and infestations | Severe | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Cardiac disorders | Severe | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Immune system disorders | Death | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Pregnancy, puerperium and perinatal conditions | Mild | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Immune system disorders | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | General disorders and administration site conditio | Death | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Gastrointestinal disorders | Death | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Cardiac disorders | Mild | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Renal and urinary disorders | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Eye disorders | Mild | 2 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Skin and subcutaneous tissue disorders | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Hepatobiliary disorders | Mild | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Renal and urinary disorders | Death | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Nervous system disorders | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Neoplasms benign, malignant, and unspecified | None | 59 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Neoplasms benign, malignant, and unspecified | Severe | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Musculoskeletal and connective tissue disorders | Moderate | 3 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Ear and labyrinth disorders | Death | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Investigations | Severe | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Skin and subcutaneous tissue disorders | Severe | 1 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Hepatobiliary disorders | Moderate | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Gastrointestinal disorders | Severe | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Psychiatric disorders | Death | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Social circumstances | Moderate | 1 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Ear and labyrinth disorders | None | 58 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Pregnancy, puerperium and perinatal conditions | Moderate | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Neoplasms benign, malignant, and unspecified | Mild | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Skin and subcutaneous tissue disorders | Mild | 6 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Pregnancy, puerperium and perinatal conditions | None | 58 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Hepatobiliary disorders | Death | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Blood and lymphatic system disorders : Mild | Moderate | 1 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Gastrointestinal disorders | None | 33 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Vascular disorders | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Musculoskeletal and connective tissue disorders | Severe | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Respiratory, thoracic and mediastinal disorders | None | 49 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Respiratory, thoracic and mediastinal disorders | Moderate | 5 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Immune system disorders | Mild | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Psychiatric disorders | None | 55 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Social circumstances | Mild | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Renal and urinary disorders | None | 45 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Vascular disorders | None | 56 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Vascular disorders | Severe | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Injury, poisoning and procedural complications | Potentically Life Threatening | 1 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | General disorders and administration site conditio | Mild | 9 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Metabolism and nutrition disorders | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Musculoskeletal and connective tissue disorders | None | 50 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Blood and lymphatic system disorders : Mild | None | 57 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Respiratory, thoracic and mediastinal disorders | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Immune system disorders | Severe | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Metabolism and nutrition disorders | Mild | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Renal and urinary disorders | Mild | 10 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Respiratory, thoracic and mediastinal disorders | Severe | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Blood and lymphatic system disorders : Mild | Mild | 1 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Respiratory, thoracic and mediastinal disorders | Mild | 5 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Respiratory, thoracic and mediastinal disorders | Death | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Neoplasms benign, malignant, and unspecified | Death | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Skin and subcutaneous tissue disorders | None | 49 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Immune system disorders | None | 59 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Reproductive system and breast disorders | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Metabolism and nutrition disorders | Moderate | 6 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Nervous system disorders | Mild | 17 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Metabolism and nutrition disorders | Death | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Social circumstances | Severe | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Infections and infestations | Mild | 11 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Skin and subcutaneous tissue disorders | Death | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Psychiatric disorders | Mild | 1 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Social circumstances | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | General disorders and administration site conditio | None | 50 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Cardiac disorders | Moderate | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Investigations | Mild | 13 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Musculoskeletal and connective tissue disorders | Death | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Vascular disorders | Death | 0 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Infections and infestations | Moderate | 25 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Infections and infestations | None | 23 Participants |
| Daily Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Nervous system disorders | Severe | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Neoplasms benign, malignant, and unspecified | Severe | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Metabolism and nutrition disorders | Mild | 3 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Vascular disorders | None | 55 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Pregnancy, puerperium and perinatal conditions | None | 59 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Blood and lymphatic system disorders : Mild | None | 57 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Infections and infestations | None | 24 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Vascular disorders | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Injury, poisoning and procedural complications | Mild | 5 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Investigations | Severe | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Blood and lymphatic system disorders : Mild | Moderate | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Neoplasms benign, malignant, and unspecified | Mild | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Social circumstances | Severe | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Injury, poisoning and procedural complications | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Blood and lymphatic system disorders : Mild | Mild | 2 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Investigations | Mild | 15 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Renal and urinary disorders | Death | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Neoplasms benign, malignant, and unspecified | Death | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Neoplasms benign, malignant, and unspecified | None | 59 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Eye disorders | Mild | 1 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Social circumstances | Moderate | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Musculoskeletal and connective tissue disorders | Severe | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Psychiatric disorders | None | 56 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Social circumstances | Mild | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Gastrointestinal disorders | None | 32 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Pregnancy, puerperium and perinatal conditions | Mild | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Skin and subcutaneous tissue disorders | None | 48 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | General disorders and administration site conditio | Mild | 5 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Renal and urinary disorders | Mild | 11 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Renal and urinary disorders | None | 46 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Neoplasms benign, malignant, and unspecified | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Skin and subcutaneous tissue disorders | Death | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | General disorders and administration site conditio | None | 52 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Reproductive system and breast disorders | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Nervous system disorders | Severe | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Gastrointestinal disorders | Mild | 17 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Skin and subcutaneous tissue disorders | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Hepatobiliary disorders | Mild | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Musculoskeletal and connective tissue disorders | Moderate | 2 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Psychiatric disorders | Death | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Skin and subcutaneous tissue disorders | Severe | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Hepatobiliary disorders | Moderate | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Respiratory, thoracic and mediastinal disorders | Mild | 5 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Skin and subcutaneous tissue disorders | Mild | 8 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Vascular disorders | Death | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Hepatobiliary disorders | Death | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Ear and labyrinth disorders | None | 56 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Pregnancy, puerperium and perinatal conditions | Moderate | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Respiratory, thoracic and mediastinal disorders | None | 52 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Immune system disorders | Mild | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Nervous system disorders | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Respiratory, thoracic and mediastinal disorders | Moderate | 2 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Renal and urinary disorders | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Respiratory, thoracic and mediastinal disorders | Death | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Metabolism and nutrition disorders | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Respiratory, thoracic and mediastinal disorders | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Immune system disorders | Severe | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Ear and labyrinth disorders | Death | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Psychiatric disorders | Mild | 3 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Musculoskeletal and connective tissue disorders | None | 51 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Immune system disorders | None | 59 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Metabolism and nutrition disorders | Death | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Cardiac disorders | Moderate | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Infections and infestations | Mild | 10 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Musculoskeletal and connective tissue disorders | Death | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Vascular disorders | Severe | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Cardiac disorders | Mild | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Infections and infestations | Moderate | 25 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Immune system disorders | Moderate | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Gastrointestinal disorders | Severe | 1 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Hepatobiliary disorders | None | 58 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | General disorders and administration site conditio | Moderate | 2 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Blood and lymphatic system disorders : Mild | Death | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Hepatobiliary disorders | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Hepatobiliary disorders | Severe | 1 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | General disorders and administration site conditio | Death | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | General disorders and administration site conditio | Severe | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | General disorders and administration site conditio | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Blood and lymphatic system disorders : Mild | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Blood and lymphatic system disorders : Mild | Severe | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Cardiac disorders | Death | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Reproductive system and breast disorders | Severe | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Neoplasms benign, malignant, and unspecified | Moderate | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Vascular disorders | Moderate | 1 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Cardiac disorders | None | 59 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Vascular disorders | Mild | 3 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Social circumstances | None | 59 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Social circumstances | Death | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Social circumstances | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Ear and labyrinth disorders | Mild | 1 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Cardiac disorders | Severe | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Skin and subcutaneous tissue disorders | Moderate | 3 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Reproductive system and breast disorders | None | 34 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Reproductive system and breast disorders | Death | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Ear and labyrinth disorders | Moderate | 2 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Reproductive system and breast disorders | Moderate | 8 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Reproductive system and breast disorders | Mild | 17 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Renal and urinary disorders | Severe | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Ear and labyrinth disorders | Severe | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Renal and urinary disorders | Moderate | 2 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Psychiatric disorders | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Psychiatric disorders | Severe | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Ear and labyrinth disorders | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Psychiatric disorders | Moderate | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Pregnancy, puerperium and perinatal conditions | Death | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Pregnancy, puerperium and perinatal conditions | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Pregnancy, puerperium and perinatal conditions | Severe | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Eye disorders | Moderate | 1 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Investigations | Moderate | 6 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Nervous system disorders | None | 34 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Nervous system disorders | Death | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Nervous system disorders | Moderate | 11 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Eye disorders | Severe | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Nervous system disorders | Mild | 14 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Musculoskeletal and connective tissue disorders | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Musculoskeletal and connective tissue disorders | Mild | 6 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Eye disorders | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Metabolism and nutrition disorders | None | 49 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Metabolism and nutrition disorders | Severe | 2 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Metabolism and nutrition disorders | Moderate | 5 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Investigations | None | 38 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Eye disorders | Death | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Gastrointestinal disorders | Moderate | 9 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Investigations | Death | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Investigations | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Injury, poisoning and procedural complications | None | 51 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Eye disorders | None | 57 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Injury, poisoning and procedural complications | Death | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Injury, poisoning and procedural complications | Severe | 1 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Injury, poisoning and procedural complications | Moderate | 2 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Gastrointestinal disorders | Death | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Cardiac disorders | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Infections and infestations | Death | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Infections and infestations | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Infections and infestations | Severe | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Gastrointestinal disorders | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Respiratory, thoracic and mediastinal disorders | Severe | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Immune system disorders | Death | 0 Participants |
| Time-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Immune system disorders | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Neoplasms benign, malignant, and unspecified | Severe | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Cardiac disorders | Severe | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Cardiac disorders | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Cardiac disorders | Death | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Cardiac disorders | None | 59 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Ear and labyrinth disorders | Mild | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Ear and labyrinth disorders | Moderate | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Ear and labyrinth disorders | Severe | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Ear and labyrinth disorders | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Eye disorders | Moderate | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Eye disorders | Severe | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Eye disorders | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Eye disorders | Death | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Eye disorders | None | 59 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Gastrointestinal disorders | Severe | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Gastrointestinal disorders | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Gastrointestinal disorders | Death | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | General disorders and administration site conditio | Moderate | 5 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | General disorders and administration site conditio | Severe | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | General disorders and administration site conditio | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | General disorders and administration site conditio | Death | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Hepatobiliary disorders | Moderate | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Hepatobiliary disorders | Severe | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Hepatobiliary disorders | Death | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Hepatobiliary disorders | None | 60 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Immune system disorders | Moderate | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Immune system disorders | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Immune system disorders | Death | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Infections and infestations | Severe | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Infections and infestations | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Infections and infestations | Death | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Injury, poisoning and procedural complications | Moderate | 1 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Injury, poisoning and procedural complications | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Injury, poisoning and procedural complications | Death | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Injury, poisoning and procedural complications | None | 46 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Investigations | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Investigations | Death | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Investigations | None | 43 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Metabolism and nutrition disorders | Moderate | 10 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Metabolism and nutrition disorders | None | 43 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Musculoskeletal and connective tissue disorders | Mild | 9 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Musculoskeletal and connective tissue disorders | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Nervous system disorders | Mild | 19 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Nervous system disorders | Moderate | 12 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Nervous system disorders | Death | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Nervous system disorders | None | 29 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Pregnancy, puerperium and perinatal conditions | Severe | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Pregnancy, puerperium and perinatal conditions | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Pregnancy, puerperium and perinatal conditions | Death | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Psychiatric disorders | Moderate | 2 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Psychiatric disorders | Severe | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Psychiatric disorders | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Renal and urinary disorders | Moderate | 3 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Renal and urinary disorders | Severe | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Renal and urinary disorders | None | 46 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Reproductive system and breast disorders | Mild | 17 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Reproductive system and breast disorders | Moderate | 8 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Reproductive system and breast disorders | Severe | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Reproductive system and breast disorders | Death | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Reproductive system and breast disorders | None | 34 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Skin and subcutaneous tissue disorders | Moderate | 4 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Social circumstances | Death | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Social circumstances | None | 60 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Vascular disorders | Mild | 1 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Vascular disorders | Moderate | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Neoplasms benign, malignant, and unspecified | Mild | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Neoplasms benign, malignant, and unspecified | Moderate | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Blood and lymphatic system disorders : Mild | Severe | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Blood and lymphatic system disorders : Mild | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Blood and lymphatic system disorders : Mild | Death | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Cardiac disorders | Moderate | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Gastrointestinal disorders | Moderate | 10 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Gastrointestinal disorders | None | 32 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Immune system disorders | None | 58 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Investigations | Moderate | 3 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Respiratory, thoracic and mediastinal disorders | Severe | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Social circumstances | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Vascular disorders | None | 59 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Psychiatric disorders | None | 56 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Nervous system disorders | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Pregnancy, puerperium and perinatal conditions | Mild | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Psychiatric disorders | Death | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Pregnancy, puerperium and perinatal conditions | Moderate | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Psychiatric disorders | Mild | 2 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Pregnancy, puerperium and perinatal conditions | None | 60 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Social circumstances | Severe | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Social circumstances | Mild | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Neoplasms benign, malignant, and unspecified | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Skin and subcutaneous tissue disorders | None | 48 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | General disorders and administration site conditio | Mild | 7 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Skin and subcutaneous tissue disorders | Death | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | General disorders and administration site conditio | None | 48 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Skin and subcutaneous tissue disorders | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Hepatobiliary disorders | Mild | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Skin and subcutaneous tissue disorders | Severe | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Hepatobiliary disorders | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Skin and subcutaneous tissue disorders | Mild | 8 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Respiratory, thoracic and mediastinal disorders | None | 50 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Immune system disorders | Mild | 1 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Ear and labyrinth disorders | None | 60 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Respiratory, thoracic and mediastinal disorders | Death | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Respiratory, thoracic and mediastinal disorders | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Immune system disorders | Severe | 1 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Musculoskeletal and connective tissue disorders | None | 50 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Infections and infestations | Mild | 15 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Renal and urinary disorders | Mild | 11 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Cardiac disorders | Mild | 1 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Infections and infestations | Moderate | 21 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Blood and lymphatic system disorders : Mild | None | 59 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Infections and infestations | None | 24 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Injury, poisoning and procedural complications | Mild | 11 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Blood and lymphatic system disorders : Mild | Moderate | 1 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Injury, poisoning and procedural complications | Severe | 2 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Blood and lymphatic system disorders : Mild | Mild | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Neoplasms benign, malignant, and unspecified | None | 60 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Investigations | Mild | 13 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Neoplasms benign, malignant, and unspecified | Death | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Investigations | Severe | 1 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Eye disorders | Mild | 1 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Vascular disorders | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Vascular disorders | Severe | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Metabolism and nutrition disorders | Mild | 7 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Social circumstances | Moderate | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Metabolism and nutrition disorders | Severe | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Ear and labyrinth disorders | Death | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Respiratory, thoracic and mediastinal disorders | Moderate | 1 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Metabolism and nutrition disorders | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Vascular disorders | Death | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Respiratory, thoracic and mediastinal disorders | Mild | 9 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Metabolism and nutrition disorders | Death | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Reproductive system and breast disorders | Potentically Life Threatening | 1 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Musculoskeletal and connective tissue disorders | Moderate | 1 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Musculoskeletal and connective tissue disorders | Severe | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Renal and urinary disorders | Death | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Musculoskeletal and connective tissue disorders | Death | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Gastrointestinal disorders | Mild | 18 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Renal and urinary disorders | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Cape Town | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Nervous system disorders | Severe | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Metabolism and nutrition disorders | Mild | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Eye disorders | Mild | 1 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Cardiac disorders | Mild | 2 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Infections and infestations | Mild | 22 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Pregnancy, puerperium and perinatal conditions | None | 60 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Skin and subcutaneous tissue disorders | Mild | 8 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Musculoskeletal and connective tissue disorders | Death | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Social circumstances | Severe | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Metabolism and nutrition disorders | Severe | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Nervous system disorders | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Musculoskeletal and connective tissue disorders | None | 43 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Immune system disorders | Severe | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Respiratory, thoracic and mediastinal disorders | Moderate | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Psychiatric disorders | Mild | 8 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Respiratory, thoracic and mediastinal disorders | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Ear and labyrinth disorders | None | 59 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Gastrointestinal disorders | Mild | 24 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Metabolism and nutrition disorders | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Renal and urinary disorders | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Immune system disorders | Mild | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Respiratory, thoracic and mediastinal disorders | Death | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Nervous system disorders | Severe | 1 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Pregnancy, puerperium and perinatal conditions | Moderate | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Metabolism and nutrition disorders | Death | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Respiratory, thoracic and mediastinal disorders | None | 24 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Hepatobiliary disorders | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Reproductive system and breast disorders | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Psychiatric disorders | Death | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Skin and subcutaneous tissue disorders | Severe | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Hepatobiliary disorders | Mild | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Pregnancy, puerperium and perinatal conditions | Mild | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Musculoskeletal and connective tissue disorders | Moderate | 4 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Skin and subcutaneous tissue disorders | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | General disorders and administration site conditio | None | 50 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Skin and subcutaneous tissue disorders | Death | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | General disorders and administration site conditio | Mild | 10 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Skin and subcutaneous tissue disorders | None | 50 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Gastrointestinal disorders | None | 30 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Social circumstances | Mild | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Investigations | Moderate | 5 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Neoplasms benign, malignant, and unspecified | Death | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Investigations | Mild | 18 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Neoplasms benign, malignant, and unspecified | None | 60 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Blood and lymphatic system disorders : Mild | Mild | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Vascular disorders | Death | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Injury, poisoning and procedural complications | Severe | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Injury, poisoning and procedural complications | Mild | 16 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Renal and urinary disorders | Mild | 1 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Investigations | Severe | 1 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Renal and urinary disorders | Death | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Vascular disorders | None | 60 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Vascular disorders | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Ear and labyrinth disorders | Death | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Blood and lymphatic system disorders : Mild | Moderate | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Infections and infestations | None | 27 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Vascular disorders | Severe | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Social circumstances | Moderate | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Blood and lymphatic system disorders : Mild | None | 60 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Infections and infestations | Moderate | 8 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Gastrointestinal disorders | Moderate | 6 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Reproductive system and breast disorders | Severe | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Injury, poisoning and procedural complications | None | 44 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Nervous system disorders | Death | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Immune system disorders | Moderate | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Psychiatric disorders | None | 52 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Nervous system disorders | None | 39 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Eye disorders | Moderate | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Vascular disorders | Mild | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Renal and urinary disorders | Severe | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Pregnancy, puerperium and perinatal conditions | Severe | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Hepatobiliary disorders | Severe | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Gastrointestinal disorders | Death | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Respiratory, thoracic and mediastinal disorders | Severe | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Cardiac disorders | None | 58 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Infections and infestations | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Pregnancy, puerperium and perinatal conditions | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Social circumstances | None | 60 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Immune system disorders | Death | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Ear and labyrinth disorders | Severe | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Injury, poisoning and procedural complications | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Pregnancy, puerperium and perinatal conditions | Death | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Ear and labyrinth disorders | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Blood and lymphatic system disorders : Mild | Death | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Psychiatric disorders | Moderate | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Social circumstances | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Social circumstances | Death | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Injury, poisoning and procedural complications | Death | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Skin and subcutaneous tissue disorders | Moderate | 2 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Psychiatric disorders | Severe | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Respiratory, thoracic and mediastinal disorders | Mild | 36 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Ear and labyrinth disorders | Mild | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Psychiatric disorders | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Hepatobiliary disorders | Moderate | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Eye disorders | None | 59 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Blood and lymphatic system disorders : Mild | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Cardiac disorders | Moderate | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Renal and urinary disorders | None | 59 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | General disorders and administration site conditio | Death | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | General disorders and administration site conditio | Severe | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Infections and infestations | Death | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Investigations | Potentically Life Threatening | 1 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Cardiac disorders | Severe | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Hepatobiliary disorders | None | 60 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Cardiac disorders | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Investigations | Death | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Renal and urinary disorders | Moderate | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | General disorders and administration site conditio | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Immune system disorders | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Eye disorders | Death | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Investigations | None | 35 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Reproductive system and breast disorders | Mild | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Metabolism and nutrition disorders | Moderate | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Blood and lymphatic system disorders : Mild | Severe | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Gastrointestinal disorders | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Cardiac disorders | Death | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Eye disorders | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Metabolism and nutrition disorders | None | 60 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | General disorders and administration site conditio | Moderate | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Neoplasms benign, malignant, and unspecified | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Musculoskeletal and connective tissue disorders | Mild | 13 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Ear and labyrinth disorders | Moderate | 1 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Infections and infestations | Severe | 3 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Neoplasms benign, malignant, and unspecified | Severe | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Musculoskeletal and connective tissue disorders | Severe | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Reproductive system and breast disorders | None | 60 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Reproductive system and breast disorders | Moderate | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Immune system disorders | None | 60 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Musculoskeletal and connective tissue disorders | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Nervous system disorders | Mild | 17 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Neoplasms benign, malignant, and unspecified | Moderate | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Eye disorders | Severe | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Reproductive system and breast disorders | Death | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Nervous system disorders | Moderate | 3 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Gastrointestinal disorders | Severe | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Neoplasms benign, malignant, and unspecified | Mild | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Injury, poisoning and procedural complications | Moderate | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Vascular disorders | Moderate | 0 Participants |
| Daily Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Hepatobiliary disorders | Death | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Hepatobiliary disorders | Death | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Cardiac disorders | Moderate | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Vascular disorders | Moderate | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Ear and labyrinth disorders | Moderate | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Investigations | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Neoplasms benign, malignant, and unspecified | Severe | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Cardiac disorders | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Nervous system disorders | Death | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Injury, poisoning and procedural complications | Moderate | 2 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Cardiac disorders | Severe | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Respiratory, thoracic and mediastinal disorders | Severe | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Vascular disorders | Mild | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | General disorders and administration site conditio | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Eye disorders | Moderate | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Injury, poisoning and procedural complications | None | 41 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Infections and infestations | Death | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Nervous system disorders | None | 41 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Eye disorders | Death | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Eye disorders | Severe | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Musculoskeletal and connective tissue disorders | Mild | 15 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Investigations | Death | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Pregnancy, puerperium and perinatal conditions | Severe | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Immune system disorders | None | 59 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Gastrointestinal disorders | Death | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Nervous system disorders | Moderate | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Nervous system disorders | Mild | 18 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Cardiac disorders | None | 58 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Blood and lymphatic system disorders : Mild | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Gastrointestinal disorders | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | General disorders and administration site conditio | Severe | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Pregnancy, puerperium and perinatal conditions | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Renal and urinary disorders | Severe | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Infections and infestations | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Social circumstances | None | 59 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Renal and urinary disorders | Moderate | 1 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Musculoskeletal and connective tissue disorders | Severe | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Investigations | None | 47 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Immune system disorders | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Social circumstances | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Injury, poisoning and procedural complications | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Ear and labyrinth disorders | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Infections and infestations | Severe | 1 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Metabolism and nutrition disorders | Moderate | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Reproductive system and breast disorders | Mild | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Psychiatric disorders | Moderate | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Eye disorders | None | 59 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Reproductive system and breast disorders | None | 59 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Social circumstances | Death | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Blood and lymphatic system disorders : Mild | Severe | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Neoplasms benign, malignant, and unspecified | Mild | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Skin and subcutaneous tissue disorders | Moderate | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Neoplasms benign, malignant, and unspecified | Moderate | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Gastrointestinal disorders | Severe | 1 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Psychiatric disorders | Severe | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Injury, poisoning and procedural complications | Death | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Psychiatric disorders | None | 49 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Reproductive system and breast disorders | Moderate | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Neoplasms benign, malignant, and unspecified | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | General disorders and administration site conditio | Moderate | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Immune system disorders | Death | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Ear and labyrinth disorders | Mild | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Eye disorders | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Psychiatric disorders | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Hepatobiliary disorders | Moderate | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Ear and labyrinth disorders | Severe | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Reproductive system and breast disorders | Severe | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Reproductive system and breast disorders | Death | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Metabolism and nutrition disorders | None | 58 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Blood and lymphatic system disorders : Mild | Death | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Renal and urinary disorders | None | 55 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | General disorders and administration site conditio | Death | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Hepatobiliary disorders | Severe | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Musculoskeletal and connective tissue disorders | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Cardiac disorders | Death | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Injury, poisoning and procedural complications | Mild | 15 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Ear and labyrinth disorders | Death | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Ear and labyrinth disorders | None | 59 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Eye disorders | Mild | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Gastrointestinal disorders | Mild | 22 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Gastrointestinal disorders | Moderate | 1 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Gastrointestinal disorders | None | 35 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | General disorders and administration site conditio | Mild | 16 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | General disorders and administration site conditio | None | 43 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Hepatobiliary disorders | Mild | 1 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Hepatobiliary disorders | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Hepatobiliary disorders | None | 58 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Immune system disorders | Mild | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Immune system disorders | Moderate | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Immune system disorders | Severe | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Infections and infestations | Mild | 33 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Infections and infestations | Moderate | 6 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Infections and infestations | None | 19 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Injury, poisoning and procedural complications | Severe | 1 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Investigations | Mild | 9 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Investigations | Moderate | 2 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Investigations | Severe | 1 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Metabolism and nutrition disorders | Mild | 1 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Metabolism and nutrition disorders | Severe | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Metabolism and nutrition disorders | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Metabolism and nutrition disorders | Death | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Musculoskeletal and connective tissue disorders | Moderate | 1 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Musculoskeletal and connective tissue disorders | None | 43 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Nervous system disorders | Severe | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Nervous system disorders | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Pregnancy, puerperium and perinatal conditions | Mild | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Pregnancy, puerperium and perinatal conditions | Moderate | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Pregnancy, puerperium and perinatal conditions | Death | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Pregnancy, puerperium and perinatal conditions | None | 59 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Psychiatric disorders | Mild | 10 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Psychiatric disorders | Death | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Renal and urinary disorders | Mild | 3 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Renal and urinary disorders | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Renal and urinary disorders | Death | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Reproductive system and breast disorders | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Respiratory, thoracic and mediastinal disorders | Mild | 23 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Respiratory, thoracic and mediastinal disorders | Moderate | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Skin and subcutaneous tissue disorders | Mild | 15 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Social circumstances | Mild | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Vascular disorders | Severe | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Vascular disorders | Death | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Vascular disorders | None | 59 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Neoplasms benign, malignant, and unspecified | Death | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Blood and lymphatic system disorders : Mild | Mild | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Blood and lymphatic system disorders : Mild | Moderate | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Blood and lymphatic system disorders : Mild | None | 59 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Cardiac disorders | Mild | 1 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Musculoskeletal and connective tissue disorders | Death | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Respiratory, thoracic and mediastinal disorders | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Respiratory, thoracic and mediastinal disorders | Death | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Respiratory, thoracic and mediastinal disorders | None | 36 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Skin and subcutaneous tissue disorders | Severe | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Skin and subcutaneous tissue disorders | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Skin and subcutaneous tissue disorders | Death | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Skin and subcutaneous tissue disorders | None | 44 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Social circumstances | Moderate | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Social circumstances | Severe | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Vascular disorders | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Neoplasms benign, malignant, and unspecified | None | 59 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Respiratory, thoracic and mediastinal disorders | Death | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Skin and subcutaneous tissue disorders | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Pregnancy, puerperium and perinatal conditions | Moderate | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | General disorders and administration site conditio | None | 47 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Immune system disorders | None | 59 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Ear and labyrinth disorders | Death | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Musculoskeletal and connective tissue disorders | Death | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Musculoskeletal and connective tissue disorders | Moderate | 2 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Skin and subcutaneous tissue disorders | Severe | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Reproductive system and breast disorders | None | 57 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Eye disorders | Mild | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Immune system disorders | Severe | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Hepatobiliary disorders | Mild | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Metabolism and nutrition disorders | Death | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Immune system disorders | Moderate | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Neoplasms benign, malignant, and unspecified | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Respiratory, thoracic and mediastinal disorders | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Nervous system disorders | Severe | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Immune system disorders | Mild | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Hepatobiliary disorders | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Respiratory, thoracic and mediastinal disorders | Mild | 29 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Hepatobiliary disorders | None | 59 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Respiratory, thoracic and mediastinal disorders | None | 29 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Pregnancy, puerperium and perinatal conditions | None | 59 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Metabolism and nutrition disorders | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Psychiatric disorders | Death | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Pregnancy, puerperium and perinatal conditions | Death | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Respiratory, thoracic and mediastinal disorders | Moderate | 1 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Metabolism and nutrition disorders | Severe | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Skin and subcutaneous tissue disorders | Mild | 10 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Musculoskeletal and connective tissue disorders | None | 44 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Social circumstances | Moderate | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Gastrointestinal disorders | Mild | 23 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Vascular disorders | Mild | 1 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Vascular disorders | Moderate | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Metabolism and nutrition disorders | Mild | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Social circumstances | Severe | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Ear and labyrinth disorders | None | 58 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Vascular disorders | Severe | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Renal and urinary disorders | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Gastrointestinal disorders | Moderate | 3 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Investigations | None | 48 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Vascular disorders | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Neoplasms benign, malignant, and unspecified | Moderate | 1 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Vascular disorders | Death | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Nervous system disorders | None | 36 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Investigations | Severe | 1 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Vascular disorders | None | 58 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Pregnancy, puerperium and perinatal conditions | Mild | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Investigations | Moderate | 3 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Neoplasms benign, malignant, and unspecified | None | 58 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Renal and urinary disorders | Mild | 2 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Neoplasms benign, malignant, and unspecified | Death | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Investigations | Mild | 7 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Gastrointestinal disorders | Death | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Musculoskeletal and connective tissue disorders | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Injury, poisoning and procedural complications | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Social circumstances | Mild | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Blood and lymphatic system disorders : Mild | Mild | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Renal and urinary disorders | Death | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Injury, poisoning and procedural complications | Severe | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Gastrointestinal disorders | None | 32 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Blood and lymphatic system disorders : Mild | Moderate | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Skin and subcutaneous tissue disorders | None | 46 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Infections and infestations | None | 19 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | General disorders and administration site conditio | Mild | 11 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Psychiatric disorders | Mild | 8 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Blood and lymphatic system disorders : Mild | None | 59 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Infections and infestations | Death | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Skin and subcutaneous tissue disorders | Death | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Reproductive system and breast disorders | Severe | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Cardiac disorders | Mild | 1 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Infections and infestations | Mild | 28 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Psychiatric disorders | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Renal and urinary disorders | Moderate | 1 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Ear and labyrinth disorders | Mild | 1 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Reproductive system and breast disorders | Death | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Renal and urinary disorders | Severe | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Reproductive system and breast disorders | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Ear and labyrinth disorders | Moderate | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Psychiatric disorders | None | 51 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Reproductive system and breast disorders | Mild | 1 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Injury, poisoning and procedural complications | Mild | 14 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Renal and urinary disorders | None | 56 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Reproductive system and breast disorders | Moderate | 1 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | General disorders and administration site conditio | Moderate | 1 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Hepatobiliary disorders | Severe | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Injury, poisoning and procedural complications | Moderate | 1 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Cardiac disorders | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Hepatobiliary disorders | Moderate | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Blood and lymphatic system disorders : Mild | Death | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Eye disorders | None | 59 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Injury, poisoning and procedural complications | Death | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Immune system disorders | Death | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | General disorders and administration site conditio | Death | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Immune system disorders | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Investigations | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | General disorders and administration site conditio | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Eye disorders | Death | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Investigations | Death | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | General disorders and administration site conditio | Severe | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Blood and lymphatic system disorders : Mild | Severe | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Metabolism and nutrition disorders | Moderate | 1 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Infections and infestations | Moderate | 10 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Eye disorders | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Social circumstances | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Metabolism and nutrition disorders | None | 58 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Neoplasms benign, malignant, and unspecified | Severe | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Musculoskeletal and connective tissue disorders | Mild | 13 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Musculoskeletal and connective tissue disorders | Severe | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Cardiac disorders | Moderate | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Infections and infestations | Severe | 2 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Eye disorders | Severe | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Nervous system disorders | Mild | 22 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Cardiac disorders | Death | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Neoplasms benign, malignant, and unspecified | Mild | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Nervous system disorders | Moderate | 1 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Hepatobiliary disorders | Death | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Nervous system disorders | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Respiratory, thoracic and mediastinal disorders | Severe | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Nervous system disorders | Death | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Eye disorders | Moderate | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Injury, poisoning and procedural complications | None | 44 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Pregnancy, puerperium and perinatal conditions | Severe | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Social circumstances | None | 59 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Pregnancy, puerperium and perinatal conditions | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Infections and infestations | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Ear and labyrinth disorders | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Cardiac disorders | Severe | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Cardiac disorders | None | 58 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Social circumstances | Death | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Psychiatric disorders | Moderate | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Gastrointestinal disorders | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Skin and subcutaneous tissue disorders | Moderate | 3 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Psychiatric disorders | Severe | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Blood and lymphatic system disorders : Mild | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Ear and labyrinth disorders | Severe | 0 Participants |
| Event-driven Dosing, Bangkok | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Gastrointestinal disorders | Severe | 1 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Cardiac disorders | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Immune system disorders | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Immune system disorders | Death | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Infections and infestations | Severe | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Gastrointestinal disorders | Severe | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Cardiac disorders | Moderate | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Infections and infestations | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Injury, poisoning and procedural complications | Mild | 17 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Injury, poisoning and procedural complications | Moderate | 2 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Eye disorders | None | 57 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Injury, poisoning and procedural complications | Death | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Injury, poisoning and procedural complications | None | 38 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Eye disorders | Death | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Investigations | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Investigations | Death | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Metabolism and nutrition disorders | Moderate | 2 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Eye disorders | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Metabolism and nutrition disorders | None | 52 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Social circumstances | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Musculoskeletal and connective tissue disorders | Mild | 13 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Musculoskeletal and connective tissue disorders | Severe | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Eye disorders | Severe | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Nervous system disorders | Mild | 16 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Nervous system disorders | Moderate | 1 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Nervous system disorders | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Eye disorders | Moderate | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Nervous system disorders | Death | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Pregnancy, puerperium and perinatal conditions | Severe | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Cardiac disorders | Severe | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Pregnancy, puerperium and perinatal conditions | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Ear and labyrinth disorders | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Psychiatric disorders | Moderate | 1 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Psychiatric disorders | Severe | 2 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Ear and labyrinth disorders | Severe | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Psychiatric disorders | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Renal and urinary disorders | Moderate | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Renal and urinary disorders | Severe | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Renal and urinary disorders | None | 47 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Ear and labyrinth disorders | Moderate | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Reproductive system and breast disorders | Mild | 1 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Reproductive system and breast disorders | Moderate | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Reproductive system and breast disorders | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Reproductive system and breast disorders | Death | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Ear and labyrinth disorders | Mild | 1 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Skin and subcutaneous tissue disorders | Mild | 8 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Skin and subcutaneous tissue disorders | Moderate | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Social circumstances | Death | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Cardiac disorders | None | 58 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Social circumstances | None | 59 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Vascular disorders | Mild | 2 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Neoplasms benign, malignant, and unspecified | Mild | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Cardiac disorders | Death | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Respiratory, thoracic and mediastinal disorders | Severe | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Neoplasms benign, malignant, and unspecified | Severe | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Blood and lymphatic system disorders : Mild | Severe | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | General disorders and administration site conditio | Severe | 1 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | General disorders and administration site conditio | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | General disorders and administration site conditio | Death | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Hepatobiliary disorders | Moderate | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | General disorders and administration site conditio | Moderate | 2 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Hepatobiliary disorders | Severe | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Hepatobiliary disorders | Death | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Blood and lymphatic system disorders : Mild | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Gastrointestinal disorders | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Skin and subcutaneous tissue disorders | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Blood and lymphatic system disorders : Mild | Mild | 2 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Nervous system disorders | None | 42 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Vascular disorders | Severe | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Blood and lymphatic system disorders : Mild | None | 57 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Gastrointestinal disorders | Death | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | General disorders and administration site conditio | None | 46 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Musculoskeletal and connective tissue disorders | Moderate | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Immune system disorders | None | 59 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Investigations | None | 50 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Injury, poisoning and procedural complications | Severe | 2 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Renal and urinary disorders | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Musculoskeletal and connective tissue disorders | Death | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Investigations | Severe | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Skin and subcutaneous tissue disorders | Severe | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Nervous system disorders | Severe | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Pregnancy, puerperium and perinatal conditions | Moderate | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Immune system disorders | Severe | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Metabolism and nutrition disorders | Death | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Vascular disorders | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Reproductive system and breast disorders | None | 58 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Skin and subcutaneous tissue disorders | Death | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Neoplasms benign, malignant, and unspecified | Death | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Infections and infestations | None | 37 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Vascular disorders | Death | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Skin and subcutaneous tissue disorders | None | 51 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Immune system disorders | Moderate | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Cardiac disorders | Mild | 1 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Neoplasms benign, malignant, and unspecified | Moderate | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Blood and lymphatic system disorders : Mild | Moderate | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Respiratory, thoracic and mediastinal disorders | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Vascular disorders | None | 57 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Hepatobiliary disorders | Mild | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Immune system disorders | Mild | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Renal and urinary disorders | Death | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Gastrointestinal disorders | Moderate | 1 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Neoplasms benign, malignant, and unspecified | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Infections and infestations | Moderate | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Respiratory, thoracic and mediastinal disorders | Death | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Pregnancy, puerperium and perinatal conditions | None | 59 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Hepatobiliary disorders | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Social circumstances | Moderate | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Hepatobiliary disorders | None | 59 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Pregnancy, puerperium and perinatal conditions | Mild | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Respiratory, thoracic and mediastinal disorders | None | 41 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Respiratory, thoracic and mediastinal disorders | Mild | 18 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Investigations | Moderate | 1 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Psychiatric disorders | Death | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Reproductive system and breast disorders | Severe | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Metabolism and nutrition disorders | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Blood and lymphatic system disorders : Mild | Death | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Gastrointestinal disorders | Mild | 28 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Renal and urinary disorders | Mild | 12 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Musculoskeletal and connective tissue disorders | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Gastrointestinal disorders | None | 30 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Respiratory, thoracic and mediastinal disorders | Moderate | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Psychiatric disorders | None | 46 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Pregnancy, puerperium and perinatal conditions | Death | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Metabolism and nutrition disorders | Severe | 2 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Investigations | Mild | 8 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Vascular disorders | Moderate | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Musculoskeletal and connective tissue disorders | None | 46 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | General disorders and administration site conditio | Mild | 10 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Ear and labyrinth disorders | None | 58 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Infections and infestations | Mild | 22 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Psychiatric disorders | Mild | 10 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Social circumstances | Severe | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Injury, poisoning and procedural complications | Potentically Life Threatening | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Infections and infestations | Death | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Metabolism and nutrition disorders | Mild | 3 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Social circumstances | Mild | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Eye disorders | Mild | 2 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Ear and labyrinth disorders | Death | 0 Participants |
| Daily Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Neoplasms benign, malignant, and unspecified | None | 59 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Investigations | None | 50 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Nervous system disorders | Severe | 1 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Renal and urinary disorders | Mild | 6 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Renal and urinary disorders | Severe | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Musculoskeletal and connective tissue disorders | None | 49 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Renal and urinary disorders | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Musculoskeletal and connective tissue disorders | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Renal and urinary disorders | Death | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Musculoskeletal and connective tissue disorders | Moderate | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Reproductive system and breast disorders | Severe | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Metabolism and nutrition disorders | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Respiratory, thoracic and mediastinal disorders | Mild | 19 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Metabolism and nutrition disorders | Severe | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Respiratory, thoracic and mediastinal disorders | Moderate | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Ear and labyrinth disorders | None | 60 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Metabolism and nutrition disorders | Mild | 4 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Social circumstances | Severe | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Vascular disorders | Severe | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Investigations | Severe | 2 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Vascular disorders | Death | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Vascular disorders | None | 60 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Investigations | Moderate | 2 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Investigations | Mild | 6 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Neoplasms benign, malignant, and unspecified | Moderate | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Injury, poisoning and procedural complications | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Injury, poisoning and procedural complications | Severe | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Blood and lymphatic system disorders : Mild | Mild | 2 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Blood and lymphatic system disorders : Mild | Moderate | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Blood and lymphatic system disorders : Mild | Death | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Infections and infestations | Death | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Ear and labyrinth disorders | Death | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Blood and lymphatic system disorders : Mild | None | 58 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Infections and infestations | Mild | 21 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Cardiac disorders | Mild | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Infections and infestations | Moderate | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Infections and infestations | None | 39 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Immune system disorders | None | 59 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Musculoskeletal and connective tissue disorders | Death | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Immune system disorders | Severe | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Reproductive system and breast disorders | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Reproductive system and breast disorders | None | 58 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Immune system disorders | Moderate | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Respiratory, thoracic and mediastinal disorders | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Respiratory, thoracic and mediastinal disorders | Death | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Hepatobiliary disorders | None | 60 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Neoplasms benign, malignant, and unspecified | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Respiratory, thoracic and mediastinal disorders | None | 41 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Hepatobiliary disorders | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Skin and subcutaneous tissue disorders | Moderate | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Hepatobiliary disorders | Mild | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Skin and subcutaneous tissue disorders | Severe | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | General disorders and administration site conditio | None | 49 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Neoplasms benign, malignant, and unspecified | Death | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Skin and subcutaneous tissue disorders | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | General disorders and administration site conditio | Mild | 10 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Skin and subcutaneous tissue disorders | Death | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Gastrointestinal disorders | None | 31 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Skin and subcutaneous tissue disorders | None | 55 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Gastrointestinal disorders | Death | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Social circumstances | Mild | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Gastrointestinal disorders | Moderate | 2 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Social circumstances | Moderate | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Gastrointestinal disorders | Mild | 27 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Vascular disorders | Moderate | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Pregnancy, puerperium and perinatal conditions | Death | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Pregnancy, puerperium and perinatal conditions | None | 60 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Pregnancy, puerperium and perinatal conditions | Moderate | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Neoplasms benign, malignant, and unspecified | None | 60 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Psychiatric disorders | Mild | 9 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Pregnancy, puerperium and perinatal conditions | Mild | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Vascular disorders | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Psychiatric disorders | Death | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Psychiatric disorders | None | 48 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Hepatobiliary disorders | Moderate | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Psychiatric disorders | Severe | 1 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Nervous system disorders | None | 47 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Ear and labyrinth disorders | Severe | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Gastrointestinal disorders | Severe | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Cardiac disorders | None | 60 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Cardiac disorders | Moderate | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Psychiatric disorders | Moderate | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Social circumstances | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Social circumstances | Death | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Infections and infestations | Severe | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Pregnancy, puerperium and perinatal conditions | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Ear and labyrinth disorders | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Gastrointestinal disorders | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Social circumstances | None | 60 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Eye disorders | Mild | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Pregnancy, puerperium and perinatal conditions | Severe | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Hepatobiliary disorders | Death | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Vascular disorders | Mild | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Cardiac disorders | Death | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Nervous system disorders | Death | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Eye disorders | Moderate | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Nervous system disorders | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Nervous system disorders | Moderate | 2 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Cardiac disorders | Severe | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Neoplasms benign, malignant, and unspecified | Mild | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Nervous system disorders | Mild | 10 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Musculoskeletal and connective tissue disorders | Severe | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Musculoskeletal and connective tissue disorders | Mild | 11 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Eye disorders | Severe | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Neoplasms benign, malignant, and unspecified | Severe | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Metabolism and nutrition disorders | None | 53 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Metabolism and nutrition disorders | Death | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Respiratory, thoracic and mediastinal disorders | Severe | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Metabolism and nutrition disorders | Moderate | 3 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Eye disorders | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Immune system disorders | Death | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Blood and lymphatic system disorders : Mild | Severe | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Cardiac disorders | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Immune system disorders | Mild | 1 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | General disorders and administration site conditio | Severe | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | General disorders and administration site conditio | Death | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Investigations | Death | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Investigations | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | General disorders and administration site conditio | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Eye disorders | Death | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Injury, poisoning and procedural complications | None | 41 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Injury, poisoning and procedural complications | Death | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Eye disorders | None | 60 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | General disorders and administration site conditio | Moderate | 1 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Blood and lymphatic system disorders : Mild | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Injury, poisoning and procedural complications | Moderate | 1 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Immune system disorders | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Hepatobiliary disorders | Severe | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Reproductive system and breast disorders | Moderate | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Reproductive system and breast disorders | Mild | 2 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Ear and labyrinth disorders | Mild | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Renal and urinary disorders | None | 50 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Ear and labyrinth disorders | Moderate | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Injury, poisoning and procedural complications | Mild | 18 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Reproductive system and breast disorders | Death | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Renal and urinary disorders | Moderate | 4 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Psychiatric disorders | Potentically Life Threatening | 2 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Infections and infestations | Potentically Life Threatening | 0 Participants |
| Time-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Skin and subcutaneous tissue disorders | Mild | 5 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Metabolism and nutrition disorders | Moderate | 4 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Nervous system disorders | None | 43 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Psychiatric disorders | Severe | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Ear and labyrinth disorders | Mild | 1 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Cardiac disorders | Moderate | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Injury, poisoning and procedural complications | Moderate | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Ear and labyrinth disorders | Severe | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Reproductive system and breast disorders | Death | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Cardiac disorders | None | 60 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Blood and lymphatic system disorders : Mild | Severe | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Eye disorders | None | 58 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Psychiatric disorders | Moderate | 1 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Injury, poisoning and procedural complications | Mild | 14 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Infections and infestations | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Infections and infestations | Severe | 1 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | General disorders and administration site conditio | Severe | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Social circumstances | Death | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Cardiac disorders | Severe | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Psychiatric disorders | Mild | 7 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Social circumstances | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Pregnancy, puerperium and perinatal conditions | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Eye disorders | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Ear and labyrinth disorders | Moderate | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Investigations | Death | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Renal and urinary disorders | Moderate | 1 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Social circumstances | None | 60 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Investigations | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Pregnancy, puerperium and perinatal conditions | Severe | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Reproductive system and breast disorders | Moderate | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Eye disorders | Mild | 2 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Nervous system disorders | Death | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Immune system disorders | Mild | 1 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Reproductive system and breast disorders | Mild | 3 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Vascular disorders | Mild | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Cardiac disorders | Death | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | General disorders and administration site conditio | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Psychiatric disorders | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | General disorders and administration site conditio | Moderate | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Nervous system disorders | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Respiratory, thoracic and mediastinal disorders | Severe | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Investigations | Severe | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Injury, poisoning and procedural complications | None | 45 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Eye disorders | Moderate | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Hepatobiliary disorders | Death | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Renal and urinary disorders | None | 52 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Neoplasms benign, malignant, and unspecified | Mild | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Gastrointestinal disorders | Severe | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Nervous system disorders | Mild | 17 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Immune system disorders | Death | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Immune system disorders | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Musculoskeletal and connective tissue disorders | Severe | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Eye disorders | Death | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Injury, poisoning and procedural complications | Death | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Hepatobiliary disorders | Severe | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Eye disorders | Severe | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Blood and lymphatic system disorders : Mild | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Reproductive system and breast disorders | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Neoplasms benign, malignant, and unspecified | Severe | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Metabolism and nutrition disorders | None | 51 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Gastrointestinal disorders | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Metabolism and nutrition disorders | Death | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Neoplasms benign, malignant, and unspecified | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Skin and subcutaneous tissue disorders | Mild | 5 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Cardiac disorders | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Hepatobiliary disorders | Moderate | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | General disorders and administration site conditio | Mild | 8 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Reproductive system and breast disorders | Severe | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Cardiac disorders | Mild | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Neoplasms benign, malignant, and unspecified | Death | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Infections and infestations | Mild | 21 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Blood and lymphatic system disorders : Mild | None | 58 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Psychiatric disorders | Death | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Skin and subcutaneous tissue disorders | Death | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Infections and infestations | Death | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Gastrointestinal disorders | None | 31 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Musculoskeletal and connective tissue disorders | Moderate | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Blood and lymphatic system disorders : Mild | Death | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Neoplasms benign, malignant, and unspecified | None | 60 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Blood and lymphatic system disorders : Mild | Moderate | 1 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Ear and labyrinth disorders | Death | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Renal and urinary disorders | Death | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Skin and subcutaneous tissue disorders | None | 55 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Ear and labyrinth disorders | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Gastrointestinal disorders | Death | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Renal and urinary disorders | Mild | 7 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Blood and lymphatic system disorders : Mild | Mild | 1 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Neoplasms benign, malignant, and unspecified | Moderate | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Injury, poisoning and procedural complications | Severe | 1 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Pregnancy, puerperium and perinatal conditions | Mild | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Social circumstances | Mild | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Injury, poisoning and procedural complications | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Gastrointestinal disorders | Moderate | 1 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Vascular disorders | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Investigations | Mild | 6 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Investigations | Moderate | 2 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Musculoskeletal and connective tissue disorders | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Social circumstances | Moderate | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Vascular disorders | None | 60 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Vascular disorders | Severe | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Gastrointestinal disorders | Mild | 28 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Renal and urinary disorders | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Psychiatric disorders | None | 52 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Investigations | None | 52 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Social circumstances | Severe | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Metabolism and nutrition disorders | Mild | 5 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Nervous system disorders | Severe | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Vascular disorders | Moderate | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Pregnancy, puerperium and perinatal conditions | Death | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Musculoskeletal and connective tissue disorders | None | 51 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Respiratory, thoracic and mediastinal disorders | Moderate | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Vascular disorders | Death | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Hepatobiliary disorders | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Metabolism and nutrition disorders | Severe | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Respiratory, thoracic and mediastinal disorders | None | 42 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Respiratory, thoracic and mediastinal disorders | Mild | 18 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Respiratory, thoracic and mediastinal disorders | Death | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Hepatobiliary disorders | None | 60 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Ear and labyrinth disorders | None | 59 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Skin and subcutaneous tissue disorders | Moderate | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Hepatobiliary disorders | Mild | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Renal and urinary disorders | Severe | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Respiratory, thoracic and mediastinal disorders | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Immune system disorders | Moderate | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Reproductive system and breast disorders | None | 57 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Immune system disorders | Severe | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Musculoskeletal and connective tissue disorders | Death | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Pregnancy, puerperium and perinatal conditions | None | 60 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Skin and subcutaneous tissue disorders | Severe | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | General disorders and administration site conditio | None | 52 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Pregnancy, puerperium and perinatal conditions | Moderate | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Metabolism and nutrition disorders | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Infections and infestations | None | 37 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Nervous system disorders | Moderate | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Infections and infestations | Moderate | 1 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Immune system disorders | None | 59 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Musculoskeletal and connective tissue disorders | Mild | 9 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | Skin and subcutaneous tissue disorders | Potentically Life Threatening | 0 Participants |
| Event-driven Dosing, Harlem | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm | General disorders and administration site conditio | Death | 0 Participants |
Secondary
Measurement of TFV-DP (Tenofovir Diphosphate) in PBMC (Peripheral Blood Mononuclear Cell)
Below we presented the percentages of total cohort with TFV-DP concentrations consistent with \>=2 pills/week in women who also report sex in the last 7 day for each arm. For Cape Town and Bangkok, TFV-DP in PBMC was analyzed, for Harlem site, the TFV-DP in DBS (dried blood spot) was analyzed. Note: PBMC \>5.2 fmol/10\^6 cells is considered as participants taken \>=2 tablets per week; DBS \>=326 fmol/punch is considered as participants taken \>=2 tablets per week
Time frame: week 10, 18 and 30, which is 4 weeks, 12 weeks, and 24 weeks after randomization
Population: Note: Not all participants were available to be analyzed at each visits below, this could be due to missed visit, drug concentration was missing, or participants did not report to have any sex in the last 7 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Daily Dosing, Cape Town | Measurement of TFV-DP (Tenofovir Diphosphate) in PBMC (Peripheral Blood Mononuclear Cell) | Week 30 | 19 Participants |
| Daily Dosing, Cape Town | Measurement of TFV-DP (Tenofovir Diphosphate) in PBMC (Peripheral Blood Mononuclear Cell) | Week 10 | 33 Participants |
| Daily Dosing, Cape Town | Measurement of TFV-DP (Tenofovir Diphosphate) in PBMC (Peripheral Blood Mononuclear Cell) | Week 18 | 29 Participants |
| Time-driven Dosing, Cape Town | Measurement of TFV-DP (Tenofovir Diphosphate) in PBMC (Peripheral Blood Mononuclear Cell) | Week 18 | 16 Participants |
| Time-driven Dosing, Cape Town | Measurement of TFV-DP (Tenofovir Diphosphate) in PBMC (Peripheral Blood Mononuclear Cell) | Week 10 | 16 Participants |
| Time-driven Dosing, Cape Town | Measurement of TFV-DP (Tenofovir Diphosphate) in PBMC (Peripheral Blood Mononuclear Cell) | Week 30 | 13 Participants |
| Event-driven Dosing, Cape Town | Measurement of TFV-DP (Tenofovir Diphosphate) in PBMC (Peripheral Blood Mononuclear Cell) | Week 18 | 10 Participants |
| Event-driven Dosing, Cape Town | Measurement of TFV-DP (Tenofovir Diphosphate) in PBMC (Peripheral Blood Mononuclear Cell) | Week 10 | 25 Participants |
| Event-driven Dosing, Cape Town | Measurement of TFV-DP (Tenofovir Diphosphate) in PBMC (Peripheral Blood Mononuclear Cell) | Week 30 | 12 Participants |
| Daily Dosing, Bangkok | Measurement of TFV-DP (Tenofovir Diphosphate) in PBMC (Peripheral Blood Mononuclear Cell) | Week 30 | 22 Participants |
| Daily Dosing, Bangkok | Measurement of TFV-DP (Tenofovir Diphosphate) in PBMC (Peripheral Blood Mononuclear Cell) | Week 10 | 31 Participants |
| Daily Dosing, Bangkok | Measurement of TFV-DP (Tenofovir Diphosphate) in PBMC (Peripheral Blood Mononuclear Cell) | Week 18 | 28 Participants |
| Time-driven Dosing, Bangkok | Measurement of TFV-DP (Tenofovir Diphosphate) in PBMC (Peripheral Blood Mononuclear Cell) | Week 30 | 18 Participants |
| Time-driven Dosing, Bangkok | Measurement of TFV-DP (Tenofovir Diphosphate) in PBMC (Peripheral Blood Mononuclear Cell) | Week 10 | 29 Participants |
| Time-driven Dosing, Bangkok | Measurement of TFV-DP (Tenofovir Diphosphate) in PBMC (Peripheral Blood Mononuclear Cell) | Week 18 | 30 Participants |
| Event-driven Dosing, Bangkok | Measurement of TFV-DP (Tenofovir Diphosphate) in PBMC (Peripheral Blood Mononuclear Cell) | Week 10 | 30 Participants |
| Event-driven Dosing, Bangkok | Measurement of TFV-DP (Tenofovir Diphosphate) in PBMC (Peripheral Blood Mononuclear Cell) | Week 18 | 24 Participants |
| Event-driven Dosing, Bangkok | Measurement of TFV-DP (Tenofovir Diphosphate) in PBMC (Peripheral Blood Mononuclear Cell) | Week 30 | 13 Participants |
| Daily Dosing, Harlem | Measurement of TFV-DP (Tenofovir Diphosphate) in PBMC (Peripheral Blood Mononuclear Cell) | Week 18 | 11 Participants |
| Daily Dosing, Harlem | Measurement of TFV-DP (Tenofovir Diphosphate) in PBMC (Peripheral Blood Mononuclear Cell) | Week 10 | 13 Participants |
| Daily Dosing, Harlem | Measurement of TFV-DP (Tenofovir Diphosphate) in PBMC (Peripheral Blood Mononuclear Cell) | Week 30 | 9 Participants |
| Time-driven Dosing, Harlem | Measurement of TFV-DP (Tenofovir Diphosphate) in PBMC (Peripheral Blood Mononuclear Cell) | Week 10 | 8 Participants |
| Time-driven Dosing, Harlem | Measurement of TFV-DP (Tenofovir Diphosphate) in PBMC (Peripheral Blood Mononuclear Cell) | Week 18 | 10 Participants |
| Time-driven Dosing, Harlem | Measurement of TFV-DP (Tenofovir Diphosphate) in PBMC (Peripheral Blood Mononuclear Cell) | Week 30 | 3 Participants |
| Event-driven Dosing, Harlem | Measurement of TFV-DP (Tenofovir Diphosphate) in PBMC (Peripheral Blood Mononuclear Cell) | Week 30 | 3 Participants |
| Event-driven Dosing, Harlem | Measurement of TFV-DP (Tenofovir Diphosphate) in PBMC (Peripheral Blood Mononuclear Cell) | Week 10 | 5 Participants |
| Event-driven Dosing, Harlem | Measurement of TFV-DP (Tenofovir Diphosphate) in PBMC (Peripheral Blood Mononuclear Cell) | Week 18 | 3 Participants |
Secondary
The Percentage of Correctly Timed Adherence (Number of Pills Taken Within the Recommended Time Frame/Number of Pills Recommended) During 24 Weeks of Follow-up Based on Weekly Interviews and Adjusted EDM (Electronic Drug Monitoring) Data
Time frame: From week 6 (randomization week) to week 30 (end of self-administered dosing)
Population: For Cape Town daily dosing arm, there are originally 60 participants, but 1 participant was later found to be HIV infected on or before randomization visit, which should make this participant not eligible for the study analysis, so we removed this participant from this table. Given this, we left 59 participants in Cape Town daily dosing arm
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Daily Dosing, Cape Town | The Percentage of Correctly Timed Adherence (Number of Pills Taken Within the Recommended Time Frame/Number of Pills Recommended) During 24 Weeks of Follow-up Based on Weekly Interviews and Adjusted EDM (Electronic Drug Monitoring) Data | 75 % of Correctly Timed Adherence |
| Time-driven Dosing, Cape Town | The Percentage of Correctly Timed Adherence (Number of Pills Taken Within the Recommended Time Frame/Number of Pills Recommended) During 24 Weeks of Follow-up Based on Weekly Interviews and Adjusted EDM (Electronic Drug Monitoring) Data | 65 % of Correctly Timed Adherence |
| Event-driven Dosing, Cape Town | The Percentage of Correctly Timed Adherence (Number of Pills Taken Within the Recommended Time Frame/Number of Pills Recommended) During 24 Weeks of Follow-up Based on Weekly Interviews and Adjusted EDM (Electronic Drug Monitoring) Data | 53 % of Correctly Timed Adherence |
| Daily Dosing, Bangkok | The Percentage of Correctly Timed Adherence (Number of Pills Taken Within the Recommended Time Frame/Number of Pills Recommended) During 24 Weeks of Follow-up Based on Weekly Interviews and Adjusted EDM (Electronic Drug Monitoring) Data | 85 % of Correctly Timed Adherence |
| Time-driven Dosing, Bangkok | The Percentage of Correctly Timed Adherence (Number of Pills Taken Within the Recommended Time Frame/Number of Pills Recommended) During 24 Weeks of Follow-up Based on Weekly Interviews and Adjusted EDM (Electronic Drug Monitoring) Data | 79 % of Correctly Timed Adherence |
| Event-driven Dosing, Bangkok | The Percentage of Correctly Timed Adherence (Number of Pills Taken Within the Recommended Time Frame/Number of Pills Recommended) During 24 Weeks of Follow-up Based on Weekly Interviews and Adjusted EDM (Electronic Drug Monitoring) Data | 65 % of Correctly Timed Adherence |
| Daily Dosing, Harlem | The Percentage of Correctly Timed Adherence (Number of Pills Taken Within the Recommended Time Frame/Number of Pills Recommended) During 24 Weeks of Follow-up Based on Weekly Interviews and Adjusted EDM (Electronic Drug Monitoring) Data | 65 % of Correctly Timed Adherence |
| Time-driven Dosing, Harlem | The Percentage of Correctly Timed Adherence (Number of Pills Taken Within the Recommended Time Frame/Number of Pills Recommended) During 24 Weeks of Follow-up Based on Weekly Interviews and Adjusted EDM (Electronic Drug Monitoring) Data | 47 % of Correctly Timed Adherence |
| Event-driven Dosing, Harlem | The Percentage of Correctly Timed Adherence (Number of Pills Taken Within the Recommended Time Frame/Number of Pills Recommended) During 24 Weeks of Follow-up Based on Weekly Interviews and Adjusted EDM (Electronic Drug Monitoring) Data | 41 % of Correctly Timed Adherence |
Secondary
The Proportion of Participants Who Discontinue All PrEP Use Based on Self-report Via CASI or Weekly Interviews
Time frame: From Week 6 to Week 30
Population: Number of participants had product hold or product discontinuation log
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Daily Dosing, Cape Town | The Proportion of Participants Who Discontinue All PrEP Use Based on Self-report Via CASI or Weekly Interviews | Other adverse experience | 6 Participants |
| Daily Dosing, Cape Town | The Proportion of Participants Who Discontinue All PrEP Use Based on Self-report Via CASI or Weekly Interviews | Other | 1 Participants |
| Daily Dosing, Cape Town | The Proportion of Participants Who Discontinue All PrEP Use Based on Self-report Via CASI or Weekly Interviews | HIV-positive result | 0 Participants |
| Daily Dosing, Cape Town | The Proportion of Participants Who Discontinue All PrEP Use Based on Self-report Via CASI or Weekly Interviews | Pregnancy | 0 Participants |
| Time-driven Dosing, Cape Town | The Proportion of Participants Who Discontinue All PrEP Use Based on Self-report Via CASI or Weekly Interviews | Pregnancy | 0 Participants |
| Time-driven Dosing, Cape Town | The Proportion of Participants Who Discontinue All PrEP Use Based on Self-report Via CASI or Weekly Interviews | Other | 2 Participants |
| Time-driven Dosing, Cape Town | The Proportion of Participants Who Discontinue All PrEP Use Based on Self-report Via CASI or Weekly Interviews | HIV-positive result | 2 Participants |
| Time-driven Dosing, Cape Town | The Proportion of Participants Who Discontinue All PrEP Use Based on Self-report Via CASI or Weekly Interviews | Other adverse experience | 3 Participants |
| Event-driven Dosing, Cape Town | The Proportion of Participants Who Discontinue All PrEP Use Based on Self-report Via CASI or Weekly Interviews | HIV-positive result | 1 Participants |
| Event-driven Dosing, Cape Town | The Proportion of Participants Who Discontinue All PrEP Use Based on Self-report Via CASI or Weekly Interviews | Pregnancy | 1 Participants |
| Event-driven Dosing, Cape Town | The Proportion of Participants Who Discontinue All PrEP Use Based on Self-report Via CASI or Weekly Interviews | Other | 1 Participants |
| Event-driven Dosing, Cape Town | The Proportion of Participants Who Discontinue All PrEP Use Based on Self-report Via CASI or Weekly Interviews | Other adverse experience | 5 Participants |
| Daily Dosing, Bangkok | The Proportion of Participants Who Discontinue All PrEP Use Based on Self-report Via CASI or Weekly Interviews | HIV-positive result | 1 Participants |
| Daily Dosing, Bangkok | The Proportion of Participants Who Discontinue All PrEP Use Based on Self-report Via CASI or Weekly Interviews | Pregnancy | 0 Participants |
| Daily Dosing, Bangkok | The Proportion of Participants Who Discontinue All PrEP Use Based on Self-report Via CASI or Weekly Interviews | Other | 5 Participants |
| Daily Dosing, Bangkok | The Proportion of Participants Who Discontinue All PrEP Use Based on Self-report Via CASI or Weekly Interviews | Other adverse experience | 6 Participants |
| Time-driven Dosing, Bangkok | The Proportion of Participants Who Discontinue All PrEP Use Based on Self-report Via CASI or Weekly Interviews | Other adverse experience | 2 Participants |
| Time-driven Dosing, Bangkok | The Proportion of Participants Who Discontinue All PrEP Use Based on Self-report Via CASI or Weekly Interviews | Pregnancy | 0 Participants |
| Time-driven Dosing, Bangkok | The Proportion of Participants Who Discontinue All PrEP Use Based on Self-report Via CASI or Weekly Interviews | HIV-positive result | 0 Participants |
| Time-driven Dosing, Bangkok | The Proportion of Participants Who Discontinue All PrEP Use Based on Self-report Via CASI or Weekly Interviews | Other | 1 Participants |
| Event-driven Dosing, Bangkok | The Proportion of Participants Who Discontinue All PrEP Use Based on Self-report Via CASI or Weekly Interviews | Pregnancy | 0 Participants |
| Event-driven Dosing, Bangkok | The Proportion of Participants Who Discontinue All PrEP Use Based on Self-report Via CASI or Weekly Interviews | Other | 4 Participants |
| Event-driven Dosing, Bangkok | The Proportion of Participants Who Discontinue All PrEP Use Based on Self-report Via CASI or Weekly Interviews | HIV-positive result | 0 Participants |
| Event-driven Dosing, Bangkok | The Proportion of Participants Who Discontinue All PrEP Use Based on Self-report Via CASI or Weekly Interviews | Other adverse experience | 1 Participants |
| Daily Dosing, Harlem | The Proportion of Participants Who Discontinue All PrEP Use Based on Self-report Via CASI or Weekly Interviews | Other | 0 Participants |
| Daily Dosing, Harlem | The Proportion of Participants Who Discontinue All PrEP Use Based on Self-report Via CASI or Weekly Interviews | HIV-positive result | 1 Participants |
| Daily Dosing, Harlem | The Proportion of Participants Who Discontinue All PrEP Use Based on Self-report Via CASI or Weekly Interviews | Other adverse experience | 1 Participants |
| Daily Dosing, Harlem | The Proportion of Participants Who Discontinue All PrEP Use Based on Self-report Via CASI or Weekly Interviews | Pregnancy | 0 Participants |
| Time-driven Dosing, Harlem | The Proportion of Participants Who Discontinue All PrEP Use Based on Self-report Via CASI or Weekly Interviews | HIV-positive result | 0 Participants |
| Time-driven Dosing, Harlem | The Proportion of Participants Who Discontinue All PrEP Use Based on Self-report Via CASI or Weekly Interviews | Pregnancy | 0 Participants |
| Time-driven Dosing, Harlem | The Proportion of Participants Who Discontinue All PrEP Use Based on Self-report Via CASI or Weekly Interviews | Other | 4 Participants |
| Time-driven Dosing, Harlem | The Proportion of Participants Who Discontinue All PrEP Use Based on Self-report Via CASI or Weekly Interviews | Other adverse experience | 3 Participants |
| Event-driven Dosing, Harlem | The Proportion of Participants Who Discontinue All PrEP Use Based on Self-report Via CASI or Weekly Interviews | Other adverse experience | 0 Participants |
| Event-driven Dosing, Harlem | The Proportion of Participants Who Discontinue All PrEP Use Based on Self-report Via CASI or Weekly Interviews | HIV-positive result | 0 Participants |
| Event-driven Dosing, Harlem | The Proportion of Participants Who Discontinue All PrEP Use Based on Self-report Via CASI or Weekly Interviews | Pregnancy | 0 Participants |
| Event-driven Dosing, Harlem | The Proportion of Participants Who Discontinue All PrEP Use Based on Self-report Via CASI or Weekly Interviews | Other | 2 Participants |