Infusion Reaction, Multiple Sclerosis
Conditions
Keywords
cetirizine, diphenhydramine
Brief summary
This 6-month randomized controlled pilot study will determine whether there is some evidence that cetirizine is better tolerated than diphenhydramine without an increase in Infusion-Related Reactions (IRRs) in subjects receiving ocrelizumab(OCR) for multiple sclerosis (MS).
Detailed description
Ocrelizumab was approved by the US Food and Drug administration in March 2017 for the indication of Relapsing Remitting Multiple Sclerosis (RRMS) and Primary Progressive Multiple Sclerosis (PPMS). The landmark studies used to gain approval found ocrelizumab (OCR) to be well tolerated, but that at least one Infusion-Related Reaction (IRR) occurred in about one-third of patients. Because of this, neurologists typically prescribe prophylactic premedication with 100mg of methylprednisolone, 1 gram of acetaminophen, and 50 mg of IV diphenhydramine. However, many patients experience extreme sedation that interferes with their lifestyle considerably. This 6-month randomized controlled pilot study will determine whether there is some evidence that cetirizine is better tolerated than diphenhydramine without an increase in IRRs. Fifty-two patients, 26 patients per arm, will be randomized in a 1:1 ratio to receive cetirizine or diphenhydramine as premedication prior to OCR infusions on day 0 (1st half dose of 300mg), day 14 (2nd half dose of 300mg) and week 24 (1st full dose of 600mg).
Interventions
DRUGcetrizine
prophylaxis
DRUGdiphenhydramine
prophylaxis
Sponsors
Genentech, Inc.
Providence Health & Services
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized, controlled, pilot study to determine there is evidence that cetirizine is non-inferior to diphenhydramine in limiting the proportion and severity of infusion related reactions to ocrelizumab infusions.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female patient with relapsing or progressive forms of Multiple Sclerosis (MS), age 18 to 70 inclusive at the time of consent. 2. Able to understand the purpose, responsibilities and risks of the study and provide signed informed consent. 3. Naïve to ocrelizumab (OCR) and will receive OCR as part of standard of care for MS treatment. 4. No evidence, in the opinion of the investigators of significant cognitive limitation or psychiatric disorder that would interfere with the conduct of the study. 5. Estimated Expanded Disability Status Scale (EDSS) of ≤ 6.5 at screening. 6. Female patients of childbearing potential must practice effective contraception and continue contraception during the study.
Exclusion criteria
1. Any mental condition of such that patient is unable to understand the nature, scope, and possible consequences of the study. 2. Evidence of active hepatitis B infection at screening. 3. Patients with untreated hepatitis C, or tuberculosis. Patients who have history of Progressive multifocal leukoencephalopathy (PML) or known to be Human Immunodeficiency Virus (HIV) positive, per standard care. 4. Any persistent or severe infection. 5. Pregnancy or lactation. 6. Significant, uncontrolled somatic disease or severe depression in the last year. 7. Current use of immunosuppressive medication, lymphocyte-depleting agents, or lymphocyte-trafficking blockers. 8. Patients with any significant comorbidity that in the opinion of the investigator, would interfere with participation in the study. 9. Any known allergy or inability to tolerate diphenhydramine or cetirizine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants With Infusion-related Reaction (IRR) on Day 0 | During or after the first-half dose of the first infusion on day 0 | The proportion of patients having an infusion-related reaction (IRR), as defined by Common Terminology Criteria (CTCAE), version 4 during or after the first-half dose of the first infusion on day 0. IRRs are documented at the infusion clinic on the day of infusion and reported by the patient at the follow-up phone call the next business day after the infusion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale for Fatigue (VAS-F) Score on Days 0, 14 and 168 | after the infusions on day 0, day 14, and day 168. | Patient reported outcomes on Visual Analog Scale for Fatigue, administered prior to starting and within 2 hours after ocrelizumab (OCR) infusion, may be completed via phone. The scale consists of various items relating to the participants' experience of fatigue and energy. Fatigue subscale ranges from 0-10 and a higher the score represents a greater fatigue for the participant. Energy subscale ranges from 0-10 and a higher the score represents a greater energy as perceived by the participant. |
| Proportion of Participants With Infusion-related Reaction (IRR) on Day 14 | during or after receiving the second half dose infusion on day 14. | The proportion of patients having an infusion-related reaction as defined by Common Terminology Criteria (CTCAE), version 4 during or after receiving the second half dose infusion on day 14 |
| Proportion of Participants With an Infusion-related Reaction (IRR) on Day 168 | during or after receiving the first full 600mg dose infusion on day 168. | The proportion of patients having an infusion-related reaction as defined by Common Terminology Criteria (CTCAE), version 4 during or after receiving the first full 600mg dose infusion on week 168 |
| Stanford Sleepiness Scale (SSS) Score on Days 0, 14, and 168 | after the infusions on day 0, day 14, and day 168. | Patient reported outcome on Stanford Sleepiness Score (SSS) administered prior to starting and within 2 hours after ocrelizumab (OCR) infusion, may be completed via phone. SSS measures sleepiness at specific times in a day. Participants will use a scale from 1 to 7 best representing their level of perceived sleepiness. The higher the score, the sleepier the subject and a lower score indicates the alertness of the subject. |
| Modified Fatigue Impact Scale (MFIS) Score on Day 168 | at day 168. | Modified Fatigue Impact Scale (MFIS) administered after the 2nd dose of OCR. Subject answers 21 questions (9 physical, 10 cognitive, and 2 psychological items) related to fatigue in the past 4 weeks with choices of frequency: 0: Never, 1: Rarely, 2: Sometimes, 3: Often, or 4: Almost always. The total MFIS score ranges from 0 to 84. A higher total score represents greater fatigue as perceived by the participants. |
| Multiple Sclerosis Impact Scale (MSIS-29) Score on Day168 | at day 168. | Multiple Sclerosis Impact Scale (MSIS-29) is administered after the 2nd dose of ocrelizumab (OCR) infusion to evaluate the physical and psychological impact of multiple sclerosis (MS). Participants rate their symptoms related to MS as 1-Not at all, 2-a little 3-Moderately or 4-Extremely on the two subscales, 20-item physical subscale and 9-item psychological subscale. The two subscales are scored by summing the responses across items, then converting to a 0-100 scale using a formula. For both subscales, higher scores indicate higher impact of MS or greater disability for the participant. Formula for physical impact subscale score: (100\*(observed score-20))/ (100-20) Formula for psychological impact subscale score: (100\*(observed score 9))/ (45-9) |
| Treatment Satisfaction Questionnaire for Medication (TSQM) Score on Days 0, 14 and 168 | After the infusions on day 0, day 14, and day 168. | Patient reported outcome on Treatment Satisfaction Questionnaire for Medication. TSQM is administered within 2 hours after ocrelizumab (OCR) infusion, may be completed via phone to assess patient treatment satisfaction for the infusion. TSQM covers four domains: Global satisfaction, Effectiveness, Side effects, and Convenience. The scores are calculated for each of the subscales, ranging from 0 to 100. Higher score indicates higher satisfaction of the participant with the treatment and lower score indicates lower satisfaction of the participant with the treatment. |
Countries
United States
Participant flow
Recruitment details
Adult patients with relapsing or progressive multiple sclerosis (MS), starting ocrelizumab (OCR)
Participants by arm
| Arm | Count |
|---|---|
| Diphenhydramine 25 mg diphenhydramine capsule, generic, sourced from Major Pharmaceuticals will be give orally 30-60 minutes prior to ocrelizumab infusion.
antihistamine: prophylaxis | 9 |
| Cetirizine 10 mg cetirizine tablet, generic, sourced from Mylan Pharmaceuticals will be give orally 30-60 minutes prior to ocrelizumab infusion.
antihistamine: prophylaxis | 10 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Diphenhydramine | Cetirizine |
|---|---|---|---|
| Age at MS diagnosis | 34.6 years | 36.7 years | 34.5 years |
| Age at MS symptoms onset | 33.9 years | 33.9 years | 33.7 years |
| Age at OCR start | 47.5 years | 46.3 years | 48.2 years |
| Age, Continuous | 36.2 years STANDARD_DEVIATION 10.6 | 34.8 years STANDARD_DEVIATION 12.3 | 37.4 years STANDARD_DEVIATION 9.4 |
| Education Associate's Degree | 5 Participants | 4 Participants | 1 Participants |
| Education Bachelor's Degree | 8 Participants | 3 Participants | 5 Participants |
| Education Graduate School | 3 Participants | 0 Participants | 3 Participants |
| Education High School | 2 Participants | 1 Participants | 1 Participants |
| Education Trade School | 1 Participants | 1 Participants | 0 Participants |
| Employment Disabled | 2 Participants | 1 Participants | 1 Participants |
| Employment Full-time | 12 Participants | 7 Participants | 5 Participants |
| Employment Not working | 4 Participants | 0 Participants | 4 Participants |
| Employment Retired | 1 Participants | 1 Participants | 0 Participants |
| From MS symptoms onset to MS Diagnosis | 8.6 weeks | 8.6 weeks | 7.4 weeks |
| MS Type Primary Progressive Multiple Sclerosis (PPMS) | 1 Participants | 1 Participants | 0 Participants |
| MS Type Relapsing-Remitting Multiple Sclerosis (RRMS) | 16 Participants | 6 Participants | 10 Participants |
| MS Type Secondary Progressive Mutiple Sclerosis (SPMS) | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 15 Participants | 7 Participants | 8 Participants |
| Reason start OCR Breakthrough disease activity on previous treatment | 8 Participants | 3 Participants | 5 Participants |
| Reason start OCR Convenience | 2 Participants | 2 Participants | 0 Participants |
| Reason start OCR First-line therapy | 5 Participants | 2 Participants | 3 Participants |
| Reason start OCR Risk reduction from prior treatment | 3 Participants | 2 Participants | 1 Participants |
| Reason start OCR Side effects of prior treatment | 1 Participants | 0 Participants | 1 Participants |
| Region of Enrollment United States | 19 Participants | 9 Participants | 10 Participants |
| Sex: Female, Male Female | 15 Participants | 6 Participants | 9 Participants |
| Sex: Female, Male Male | 4 Participants | 3 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 10 |
| other Total, other adverse events | 7 / 9 | 8 / 10 |
| serious Total, serious adverse events | 0 / 9 | 0 / 10 |
Outcome results
Primary
Proportion of Participants With Infusion-related Reaction (IRR) on Day 0
The proportion of patients having an infusion-related reaction (IRR), as defined by Common Terminology Criteria (CTCAE), version 4 during or after the first-half dose of the first infusion on day 0. IRRs are documented at the infusion clinic on the day of infusion and reported by the patient at the follow-up phone call the next business day after the infusion.
Time frame: During or after the first-half dose of the first infusion on day 0
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Diphenhydramine | Proportion of Participants With Infusion-related Reaction (IRR) on Day 0 | 5 participnats |
| Cetirizine | Proportion of Participants With Infusion-related Reaction (IRR) on Day 0 | 6 participnats |
Secondary
Modified Fatigue Impact Scale (MFIS) Score on Day 168
Modified Fatigue Impact Scale (MFIS) administered after the 2nd dose of OCR. Subject answers 21 questions (9 physical, 10 cognitive, and 2 psychological items) related to fatigue in the past 4 weeks with choices of frequency: 0: Never, 1: Rarely, 2: Sometimes, 3: Often, or 4: Almost always. The total MFIS score ranges from 0 to 84. A higher total score represents greater fatigue as perceived by the participants.
Time frame: at day 168.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diphenhydramine | Modified Fatigue Impact Scale (MFIS) Score on Day 168 | 23.9 score on a scale | Standard Deviation 15.9 |
| Cetirizine | Modified Fatigue Impact Scale (MFIS) Score on Day 168 | 18.3 score on a scale | Standard Deviation 22.2 |
Secondary
Multiple Sclerosis Impact Scale (MSIS-29) Score on Day168
Multiple Sclerosis Impact Scale (MSIS-29) is administered after the 2nd dose of ocrelizumab (OCR) infusion to evaluate the physical and psychological impact of multiple sclerosis (MS). Participants rate their symptoms related to MS as 1-Not at all, 2-a little 3-Moderately or 4-Extremely on the two subscales, 20-item physical subscale and 9-item psychological subscale. The two subscales are scored by summing the responses across items, then converting to a 0-100 scale using a formula. For both subscales, higher scores indicate higher impact of MS or greater disability for the participant. Formula for physical impact subscale score: (100\*(observed score-20))/ (100-20) Formula for psychological impact subscale score: (100\*(observed score 9))/ (45-9)
Time frame: at day 168.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diphenhydramine | Multiple Sclerosis Impact Scale (MSIS-29) Score on Day168 | Physical Subscale | 19.7 score on a scale | Standard Deviation 25.7 |
| Diphenhydramine | Multiple Sclerosis Impact Scale (MSIS-29) Score on Day168 | Psychological Subscale | 13.0 score on a scale | Standard Deviation 10.2 |
| Cetirizine | Multiple Sclerosis Impact Scale (MSIS-29) Score on Day168 | Physical Subscale | 6.38 score on a scale | Standard Deviation 9.31 |
| Cetirizine | Multiple Sclerosis Impact Scale (MSIS-29) Score on Day168 | Psychological Subscale | 12.3 score on a scale | Standard Deviation 14.1 |
Secondary
Proportion of Participants With an Infusion-related Reaction (IRR) on Day 168
The proportion of patients having an infusion-related reaction as defined by Common Terminology Criteria (CTCAE), version 4 during or after receiving the first full 600mg dose infusion on week 168
Time frame: during or after receiving the first full 600mg dose infusion on day 168.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Diphenhydramine | Proportion of Participants With an Infusion-related Reaction (IRR) on Day 168 | 7 participants |
| Cetirizine | Proportion of Participants With an Infusion-related Reaction (IRR) on Day 168 | 8 participants |
Secondary
Proportion of Participants With Infusion-related Reaction (IRR) on Day 14
The proportion of patients having an infusion-related reaction as defined by Common Terminology Criteria (CTCAE), version 4 during or after receiving the second half dose infusion on day 14
Time frame: during or after receiving the second half dose infusion on day 14.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Diphenhydramine | Proportion of Participants With Infusion-related Reaction (IRR) on Day 14 | 6 participants |
| Cetirizine | Proportion of Participants With Infusion-related Reaction (IRR) on Day 14 | 8 participants |
Secondary
Stanford Sleepiness Scale (SSS) Score on Days 0, 14, and 168
Patient reported outcome on Stanford Sleepiness Score (SSS) administered prior to starting and within 2 hours after ocrelizumab (OCR) infusion, may be completed via phone. SSS measures sleepiness at specific times in a day. Participants will use a scale from 1 to 7 best representing their level of perceived sleepiness. The higher the score, the sleepier the subject and a lower score indicates the alertness of the subject.
Time frame: after the infusions on day 0, day 14, and day 168.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diphenhydramine | Stanford Sleepiness Scale (SSS) Score on Days 0, 14, and 168 | Day 0 | 3.11 score on a scale | Standard Deviation 1.27 |
| Diphenhydramine | Stanford Sleepiness Scale (SSS) Score on Days 0, 14, and 168 | Day 14 | 3.13 score on a scale | Standard Deviation 1.13 |
| Diphenhydramine | Stanford Sleepiness Scale (SSS) Score on Days 0, 14, and 168 | Day 168 | 2.50 score on a scale | Standard Deviation 0.837 |
| Cetirizine | Stanford Sleepiness Scale (SSS) Score on Days 0, 14, and 168 | Day 0 | 1.90 score on a scale | Standard Deviation 0.876 |
| Cetirizine | Stanford Sleepiness Scale (SSS) Score on Days 0, 14, and 168 | Day 14 | 2.00 score on a scale | Standard Deviation 0.667 |
| Cetirizine | Stanford Sleepiness Scale (SSS) Score on Days 0, 14, and 168 | Day 168 | 2.33 score on a scale | Standard Deviation 1 |
Secondary
Treatment Satisfaction Questionnaire for Medication (TSQM) Score on Days 0, 14 and 168
Patient reported outcome on Treatment Satisfaction Questionnaire for Medication. TSQM is administered within 2 hours after ocrelizumab (OCR) infusion, may be completed via phone to assess patient treatment satisfaction for the infusion. TSQM covers four domains: Global satisfaction, Effectiveness, Side effects, and Convenience. The scores are calculated for each of the subscales, ranging from 0 to 100. Higher score indicates higher satisfaction of the participant with the treatment and lower score indicates lower satisfaction of the participant with the treatment.
Time frame: After the infusions on day 0, day 14, and day 168.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diphenhydramine | Treatment Satisfaction Questionnaire for Medication (TSQM) Score on Days 0, 14 and 168 | Global Satisfaction- Day 0 | 88.0 score on a scale | Standard Deviation 15.7 |
| Diphenhydramine | Treatment Satisfaction Questionnaire for Medication (TSQM) Score on Days 0, 14 and 168 | Effectiveness- Day 0 | 78.7 score on a scale | Standard Deviation 18.2 |
| Diphenhydramine | Treatment Satisfaction Questionnaire for Medication (TSQM) Score on Days 0, 14 and 168 | Side Effects- Day 0 | 94.4 score on a scale | Standard Deviation 11 |
| Diphenhydramine | Treatment Satisfaction Questionnaire for Medication (TSQM) Score on Days 0, 14 and 168 | Convenience- Day 0 | 87.6 score on a scale | Standard Deviation 13.9 |
| Diphenhydramine | Treatment Satisfaction Questionnaire for Medication (TSQM) Score on Days 0, 14 and 168 | Global Satisfaction- Day 14 | 88.6 score on a scale | Standard Deviation 14.7 |
| Diphenhydramine | Treatment Satisfaction Questionnaire for Medication (TSQM) Score on Days 0, 14 and 168 | Effectiveness- Day 14 | 78.1 score on a scale | Standard Deviation 14 |
| Diphenhydramine | Treatment Satisfaction Questionnaire for Medication (TSQM) Score on Days 0, 14 and 168 | Side Effects- Day 14 | 92.7 score on a scale | Standard Deviation 10.4 |
| Diphenhydramine | Treatment Satisfaction Questionnaire for Medication (TSQM) Score on Days 0, 14 and 168 | Convenience- Day 14 | 90.3 score on a scale | Standard Deviation 11 |
| Diphenhydramine | Treatment Satisfaction Questionnaire for Medication (TSQM) Score on Days 0, 14 and 168 | Global Satisfaction- Day 168 | 91.7 score on a scale | Standard Deviation 13.9 |
| Diphenhydramine | Treatment Satisfaction Questionnaire for Medication (TSQM) Score on Days 0, 14 and 168 | Effectiveness- Day 168 | 87.5 score on a scale | Standard Deviation 15.6 |
| Diphenhydramine | Treatment Satisfaction Questionnaire for Medication (TSQM) Score on Days 0, 14 and 168 | Side Effects- day 168 | 95.8 score on a scale | Standard Deviation 6.98 |
| Diphenhydramine | Treatment Satisfaction Questionnaire for Medication (TSQM) Score on Days 0, 14 and 168 | Convenience- Day 168 | 94.4 score on a scale | Standard Deviation 7.04 |
| Cetirizine | Treatment Satisfaction Questionnaire for Medication (TSQM) Score on Days 0, 14 and 168 | Side Effects- day 168 | 96.3 score on a scale | Standard Deviation 11 |
| Cetirizine | Treatment Satisfaction Questionnaire for Medication (TSQM) Score on Days 0, 14 and 168 | Global Satisfaction- Day 0 | 90.8 score on a scale | Standard Deviation 9.99 |
| Cetirizine | Treatment Satisfaction Questionnaire for Medication (TSQM) Score on Days 0, 14 and 168 | Side Effects- Day 14 | 100 score on a scale | Standard Deviation 0 |
| Cetirizine | Treatment Satisfaction Questionnaire for Medication (TSQM) Score on Days 0, 14 and 168 | Effectiveness- Day 0 | 86.7 score on a scale | Standard Deviation 11.2 |
| Cetirizine | Treatment Satisfaction Questionnaire for Medication (TSQM) Score on Days 0, 14 and 168 | Effectiveness- Day 168 | 93.5 score on a scale | Standard Deviation 10 |
| Cetirizine | Treatment Satisfaction Questionnaire for Medication (TSQM) Score on Days 0, 14 and 168 | Side Effects- Day 0 | 100 score on a scale | Standard Deviation 0 |
| Cetirizine | Treatment Satisfaction Questionnaire for Medication (TSQM) Score on Days 0, 14 and 168 | Convenience- Day 14 | 96.6 score on a scale | Standard Deviation 7.33 |
| Cetirizine | Treatment Satisfaction Questionnaire for Medication (TSQM) Score on Days 0, 14 and 168 | Convenience- Day 0 | 96.1 score on a scale | Standard Deviation 5.89 |
| Cetirizine | Treatment Satisfaction Questionnaire for Medication (TSQM) Score on Days 0, 14 and 168 | Convenience- Day 168 | 95.7 score on a scale | Standard Deviation 10.9 |
| Cetirizine | Treatment Satisfaction Questionnaire for Medication (TSQM) Score on Days 0, 14 and 168 | Global Satisfaction- Day 14 | 93.3 score on a scale | Standard Deviation 11.7 |
| Cetirizine | Treatment Satisfaction Questionnaire for Medication (TSQM) Score on Days 0, 14 and 168 | Global Satisfaction- Day 168 | 99.1 score on a scale | Standard Deviation 2.67 |
| Cetirizine | Treatment Satisfaction Questionnaire for Medication (TSQM) Score on Days 0, 14 and 168 | Effectiveness- Day 14 | 91.9 score on a scale | Standard Deviation 14.2 |
Secondary
Visual Analog Scale for Fatigue (VAS-F) Score on Days 0, 14 and 168
Patient reported outcomes on Visual Analog Scale for Fatigue, administered prior to starting and within 2 hours after ocrelizumab (OCR) infusion, may be completed via phone. The scale consists of various items relating to the participants' experience of fatigue and energy. Fatigue subscale ranges from 0-10 and a higher the score represents a greater fatigue for the participant. Energy subscale ranges from 0-10 and a higher the score represents a greater energy as perceived by the participant.
Time frame: after the infusions on day 0, day 14, and day 168.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diphenhydramine | Visual Analog Scale for Fatigue (VAS-F) Score on Days 0, 14 and 168 | Energy- Day 168 | 5.33 score on a scale | Standard Deviation 2.66 |
| Diphenhydramine | Visual Analog Scale for Fatigue (VAS-F) Score on Days 0, 14 and 168 | Fatigue- Day 0 | 4.10 score on a scale | Standard Deviation 2.19 |
| Diphenhydramine | Visual Analog Scale for Fatigue (VAS-F) Score on Days 0, 14 and 168 | Energy at Day 0 | 5.20 score on a scale | Standard Deviation 1.35 |
| Diphenhydramine | Visual Analog Scale for Fatigue (VAS-F) Score on Days 0, 14 and 168 | Fatigue- Day 14 | 3.95 score on a scale | Standard Deviation 1.94 |
| Diphenhydramine | Visual Analog Scale for Fatigue (VAS-F) Score on Days 0, 14 and 168 | Energy- Day 14 | 4.63 score on a scale | Standard Deviation 1.98 |
| Diphenhydramine | Visual Analog Scale for Fatigue (VAS-F) Score on Days 0, 14 and 168 | Fatigue- Day 168 | 3.52 score on a scale | Standard Deviation 1.08 |
| Cetirizine | Visual Analog Scale for Fatigue (VAS-F) Score on Days 0, 14 and 168 | Energy- Day 14 | 6.08 score on a scale | Standard Deviation 1.8 |
| Cetirizine | Visual Analog Scale for Fatigue (VAS-F) Score on Days 0, 14 and 168 | Energy- Day 168 | 5.82 score on a scale | Standard Deviation 2.43 |
| Cetirizine | Visual Analog Scale for Fatigue (VAS-F) Score on Days 0, 14 and 168 | Fatigue- Day 14 | 1.94 score on a scale | Standard Deviation 1.12 |
| Cetirizine | Visual Analog Scale for Fatigue (VAS-F) Score on Days 0, 14 and 168 | Fatigue- Day 0 | 1.92 score on a scale | Standard Deviation 2.13 |
| Cetirizine | Visual Analog Scale for Fatigue (VAS-F) Score on Days 0, 14 and 168 | Fatigue- Day 168 | 2.12 score on a scale | Standard Deviation 2.12 |
| Cetirizine | Visual Analog Scale for Fatigue (VAS-F) Score on Days 0, 14 and 168 | Energy at Day 0 | 6.28 score on a scale | Standard Deviation 2.56 |