Intestinal Amebiasis
Conditions
Brief summary
This Study is intended to evaluate the safety and effectiveness of Ameparomo Capsules 250 mg under actual medical practice.
Interventions
None listed
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
15 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Patients with no history of using this product
Exclusion criteria
* No
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Drug Reactions | 38 days at maximum | An adverse drug reaction (ADR) was any untoward medical occurrence attributed to AMEPAROMO capsules in a participant who received AMEPAROMO capsules. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to AMEPAROMO capsules was assessed by the physician. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Cyst Negative | 10 days + 3 months at maximum | Proportion of cyst negative, which was defined as the percentage of participants with negative results in the examination of cysts after AMEPAROMO capsules up to 3 months after the completion of observation period or discontinuation of treatment, was presented along with its 2-sided 95% CI. The results of the examination of cysts were assessed as negative , positive, or indeterminate. |
| Overall Clinical Response Rate | 10 days at maximum | Clinical response rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented along with its 2-sided 95% CI. Clinical response of AMEPAROMO capsules was assessed as effective, not effective, or indeterminate by the physician based on the clinical course at the end of the observation period or at the time of treatment discontinuation. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AMEPAROMO Capsules (Paromomycin) Participants who received AMEPAROMO capsules as indicated in the approved local product document were observed for a period of 10 days at maximum. The dosage can be adjusted as per physician's discretion. | 115 |
| Total | 115 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | No visit after the first prescription | 5 |
Baseline characteristics
| Characteristic | AMEPAROMO Capsules (Paromomycin) | — |
|---|---|---|
| Age, Customized ≥15 to <65 years | 100 Participants | — |
| Age, Customized <15 years | 0 Participants | — |
| Age, Customized ≥ 65 years | 15 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 11 Participants | — |
| Sex: Female, Male Male | 104 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 115 |
| other Total, other adverse events | 18 / 115 |
| serious Total, serious adverse events | 0 / 115 |
Outcome results
Primary
Number of Participants With Adverse Drug Reactions
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to AMEPAROMO capsules in a participant who received AMEPAROMO capsules. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to AMEPAROMO capsules was assessed by the physician.
Time frame: 38 days at maximum
Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received AMEPAROMO capsules at least once.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AMEPAROMO Capsules (Paromomycin) | Number of Participants With Adverse Drug Reactions | ADRs | 15 Particpants |
| AMEPAROMO Capsules (Paromomycin) | Number of Participants With Adverse Drug Reactions | Serious ADRs | 0 Particpants |
Secondary
Overall Clinical Response Rate
Clinical response rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented along with its 2-sided 95% CI. Clinical response of AMEPAROMO capsules was assessed as effective, not effective, or indeterminate by the physician based on the clinical course at the end of the observation period or at the time of treatment discontinuation.
Time frame: 10 days at maximum
Population: The clinical response analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at the end of the observation period or at the time of treatment discontinuation. Participants with non-target disease (9) and participants who assessed as indeterminate at the final observation (6) were excluded.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AMEPAROMO Capsules (Paromomycin) | Overall Clinical Response Rate | 99.0 Percentage of Participants |
Secondary
Proportion of Cyst Negative
Proportion of cyst negative, which was defined as the percentage of participants with negative results in the examination of cysts after AMEPAROMO capsules up to 3 months after the completion of observation period or discontinuation of treatment, was presented along with its 2-sided 95% CI. The results of the examination of cysts were assessed as negative , positive, or indeterminate.
Time frame: 10 days + 3 months at maximum
Population: The cyst analysis set consists of the participants in the safety analysis set who have undergone the cyst examination at the end of the observation period or at the time of treatment discontinuation. Participants with no information on cyst examination (53) and those with non-target disease (9) were excluded.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AMEPAROMO Capsules (Paromomycin) | Proportion of Cyst Negative | 98.1 Percentage of Participants |