TriangleNCT02653976 · OUTCOME
Number of Participants With Adverse Events (AEs)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
What was measured
AE was defined as any untoward medical occurrence in a participant administered the study drug. AE included clinically significant changes in laboratory values, vital signs, and electrocardiograms. Drug-related AE was defined as AE that there was at least a reasonable possibility to have the causal relationship to the study drug. The severity of AE was evaluated by the investigator according to Common Terminology Criteria for Adverse Events (Version 4.0) where Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe or medically significant but not immediately life-threatening), Grade 4 (life-threatening consequences) and Grade 5 (death related to AE).
Groups in this outcome
SP-02L (Darinaparsin for Injection)
SP-02L (darinaparsin for injection): Darinaparsin 300 mg/m2 once daily for 5 consecutive days every 21 days
| Group | Source count |
|---|---|
| SP-02L (Darinaparsin for Injection) | 65 |
Reported measurements
AE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| SP-02L (Darinaparsin for Injection) | 64 | Not reported | Not reported | Not reported | Not reported |
Drug-related AE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| SP-02L (Darinaparsin for Injection) | 45 | Not reported | Not reported | Not reported | Not reported |
Grade ≥3 AE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| SP-02L (Darinaparsin for Injection) | 41 | Not reported | Not reported | Not reported | Not reported |
Grade ≥3 Drug-related AE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| SP-02L (Darinaparsin for Injection) | 19 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 64
- title
- AE
- categories
- measurements
- group Id
- OG000
- value
- 45
- title
- Drug-related AE
- categories
- measurements
- group Id
- OG000
- value
- 41
- title
- Grade ≥3 AE
- categories
- measurements
- group Id
- OG000
- value
- 19
- title
- Grade ≥3 Drug-related AE
- denoms
- counts
- group Id
- OG000
- value
- 65
- units
- Participants
- description
- AE was defined as any untoward medical occurrence in a participant administered the study drug. AE included clinically significant changes in laboratory values, vital signs, and electrocardiograms. Drug-related AE was defined as AE that there was at least a reasonable possibility to have the causal relationship to the study drug. The severity of AE was evaluated by the investigator according to Common Terminology Criteria for Adverse Events (Version 4.0) where Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe or medically significant but not immediately life-threatening), Grade 4 (life-threatening consequences) and Grade 5 (death related to AE).
- groups
- description
- SP-02L (darinaparsin for injection): Darinaparsin 300 mg/m2 once daily for 5 consecutive days every 21 days
- id
- OG000
- title
- SP-02L (Darinaparsin for Injection)
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
- title
- Number of Participants With Adverse Events (AEs)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice