TriangleNCT02564900 · OUTCOME
Overview of Treatment-emergent Adverse Events
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
- Baseline up to 28 days after the last dose of study drug, up to 3 years 5 months
What was measured
Treatment-emergent adverse events were graded by Common Terminology Criteria for Adverse Events, v4.03.
Analysis population: Safety events were assessed in the Safety Analysis Set. It was prespecified in the protocol that single patients with unique tumor types would be combined into 1 group for the safety analysis. For the safety overview, TEAEs for HER2-expressing NSCLC, Colorectal, and Other Solid Tumors (excluding 1 HER2-low gastric cancer subject who received 5.4 mg/kg) were combined and reported together.
Groups in this outcome
Dose Escalation: Cohort 1, 0.8 mg/kg
Participants in Cohort 1 received an intravenous 0.8 mg/kg dose of DS-8201a (FL-DP1).
Dose Escalation: Cohort 2, 1.6 mg/kg
Participants in Cohort 2 received an intravenous 1.6 mg/kg dose of DS-8201a (FL-DP1).
Dose Escalation: Cohort 3, 3.2 mg/kg
Participants in Cohort 3 received an intravenous 3.2 mg/kg dose of DS-8201a (FL-DP1).
Dose Escalation: Cohort 4, 5.4 mg/kg
Participants in Cohort 4 received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
Dose Escalation: Cohort 5, 6.4 mg/kg
Participants in Cohort 5 received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Dose Escalation: Cohort 6, 8.0 mg/kg
Participants in Cohort 6 received an intravenous 8.0 mg/kg dose of DS-8201a (FL-DP1).
Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg
Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg
Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg
Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg
Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Dose Expansion: HER2-expressing Other Solid Tumors
Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
| Group | Source count |
|---|---|
| Dose Escalation: Cohort 1, 0.8 mg/kg | 3 |
| Dose Escalation: Cohort 2, 1.6 mg/kg | 3 |
| Dose Escalation: Cohort 3, 3.2 mg/kg | 3 |
| Dose Escalation: Cohort 4, 5.4 mg/kg | 6 |
| Dose Escalation: Cohort 5, 6.4 mg/kg | 6 |
| Dose Escalation: Cohort 6, 8.0 mg/kg | 6 |
| Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg | 50 |
| Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg | 66 |
| Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg | 21 |
| Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg | 33 |
| Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg | 19 |
| Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg | 25 |
| Dose Expansion: HER2-expressing Other Solid Tumors | 59 |
Reported measurements
Treatment-emergent adverse events (TEAEs)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation: Cohort 1, 0.8 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 2, 1.6 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 3, 3.2 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 4, 5.4 mg/kg | 6 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 5, 6.4 mg/kg | 6 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 6, 8.0 mg/kg | 6 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg | 50 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg | 66 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg | 20 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg | 33 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg | 19 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg | 25 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-expressing Other Solid Tumors | 59 | Not reported | Not reported | Not reported | Not reported |
Drug-related TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation: Cohort 1, 0.8 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 2, 1.6 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 3, 3.2 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 4, 5.4 mg/kg | 6 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 5, 6.4 mg/kg | 6 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 6, 8.0 mg/kg | 6 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg | 50 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg | 66 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg | 20 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg | 33 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg | 18 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg | 25 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-expressing Other Solid Tumors | 59 | Not reported | Not reported | Not reported | Not reported |
TEAEs ≥Grade 3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation: Cohort 1, 0.8 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 2, 1.6 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 3, 3.2 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 4, 5.4 mg/kg | 5 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 5, 6.4 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 6, 8.0 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg | 23 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg | 42 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg | 11 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg | 23 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg | 10 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg | 20 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-expressing Other Solid Tumors | 37 | Not reported | Not reported | Not reported | Not reported |
Drug-related TEAEs ≥Grade 3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation: Cohort 1, 0.8 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 2, 1.6 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 3, 3.2 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 4, 5.4 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 5, 6.4 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 6, 8.0 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg | 18 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg | 37 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg | 8 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg | 20 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg | 8 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg | 16 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-expressing Other Solid Tumors | 30 | Not reported | Not reported | Not reported | Not reported |
Serious TEAEs (including AEs ending in death)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation: Cohort 1, 0.8 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 2, 1.6 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 3, 3.2 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 4, 5.4 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 5, 6.4 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 6, 8.0 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg | 11 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg | 17 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg | 12 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg | 4 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg | 7 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-expressing Other Solid Tumors | 18 | Not reported | Not reported | Not reported | Not reported |
Drug-related serious TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation: Cohort 1, 0.8 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 2, 1.6 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 3, 3.2 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 4, 5.4 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 5, 6.4 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 6, 8.0 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg | 4 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg | 11 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg | 8 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-expressing Other Solid Tumors | 9 | Not reported | Not reported | Not reported | Not reported |
TEAEs associated with death
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation: Cohort 1, 0.8 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 2, 1.6 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 3, 3.2 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 4, 5.4 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 5, 6.4 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 6, 8.0 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-expressing Other Solid Tumors | 5 | Not reported | Not reported | Not reported | Not reported |
Drug-related TEAEs associated with death
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation: Cohort 1, 0.8 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 2, 1.6 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 3, 3.2 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 4, 5.4 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 5, 6.4 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 6, 8.0 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-expressing Other Solid Tumors | 2 | Not reported | Not reported | Not reported | Not reported |
TEAEs associated with discontinuation of drug
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation: Cohort 1, 0.8 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 2, 1.6 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 3, 3.2 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 4, 5.4 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 5, 6.4 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 6, 8.0 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg | 7 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg | 22 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg | 11 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg | 4 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-expressing Other Solid Tumors | 5 | Not reported | Not reported | Not reported | Not reported |
Related TEAEs associated with drug discontinuation
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation: Cohort 1, 0.8 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 2, 1.6 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 3, 3.2 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 4, 5.4 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 5, 6.4 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 6, 8.0 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg | 5 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg | 21 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg | 11 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-expressing Other Solid Tumors | 5 | Not reported | Not reported | Not reported | Not reported |
TEAEs associated with dose reduction
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation: Cohort 1, 0.8 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 2, 1.6 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 3, 3.2 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 4, 5.4 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 5, 6.4 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 6, 8.0 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg | 5 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg | 18 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg | 9 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg | 5 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg | 9 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-expressing Other Solid Tumors | 14 | Not reported | Not reported | Not reported | Not reported |
Drug-related TEAEs associated with dose reduction
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation: Cohort 1, 0.8 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 2, 1.6 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 3, 3.2 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 4, 5.4 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 5, 6.4 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 6, 8.0 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg | 4 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg | 18 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg | 9 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg | 4 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg | 9 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-expressing Other Solid Tumors | 13 | Not reported | Not reported | Not reported | Not reported |
TEAEs associated with dose interruption
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation: Cohort 1, 0.8 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 2, 1.6 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 3, 3.2 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 4, 5.4 mg/kg | 6 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 5, 6.4 mg/kg | 4 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 6, 8.0 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg | 21 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg | 36 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg | 8 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg | 13 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg | 9 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg | 13 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-expressing Other Solid Tumors | 22 | Not reported | Not reported | Not reported | Not reported |
Related TEAEs associated with dose interruption
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation: Cohort 1, 0.8 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 2, 1.6 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 3, 3.2 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 4, 5.4 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 5, 6.4 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 6, 8.0 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg | 15 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg | 28 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg | 7 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg | 11 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg | 5 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg | 11 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-expressing Other Solid Tumors | 17 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 6
- group Id
- OG006
- value
- 50
- group Id
- OG007
- value
- 66
- group Id
- OG008
- value
- 20
- group Id
- OG009
- value
- 33
- group Id
- OG010
- value
- 19
- group Id
- OG011
- value
- 25
- title
- Treatment-emergent adverse events (TEAEs)
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 6
- group Id
- OG006
- value
- 50
- group Id
- OG007
- value
- 66
- group Id
- OG008
- value
- 20
- group Id
- OG009
- value
- 33
- group Id
- OG010
- value
- 18
- group Id
- OG011
- value
- 25
- title
- Drug-related TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 23
- group Id
- OG007
- value
- 42
- group Id
- OG008
- value
- 11
- group Id
- OG009
- value
- 23
- group Id
- OG010
- value
- 10
- group Id
- OG011
- value
- 20
- title
- TEAEs ≥Grade 3
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 18
- group Id
- OG007
- value
- 37
- group Id
- OG008
- value
- 8
- group Id
- OG009
- value
- 20
- group Id
- OG010
- value
- 8
- group Id
- OG011
- value
- 16
- title
- Drug-related TEAEs ≥Grade 3
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 11
- group Id
- OG007
- value
- 17
- group Id
- OG008
- value
- 3
- group Id
- OG009
- value
- 12
- group Id
- OG010
- value
- 4
- group Id
- OG011
- value
- 7
- title
- Serious TEAEs (including AEs ending in death)
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 11
- group Id
- OG008
- value
- 2
- group Id
- OG009
- value
- 8
- group Id
- OG010
- value
- 1
- group Id
- OG011
- value
- 3
- title
- Drug-related serious TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 2
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 1
- title
- TEAEs associated with death
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 2
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- title
- Drug-related TEAEs associated with death
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 7
- group Id
- OG007
- value
- 22
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 11
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 4
- title
- TEAEs associated with discontinuation of drug
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 5
- group Id
- OG007
- value
- 21
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 11
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 3
- title
- Related TEAEs associated with drug discontinuation
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 5
- group Id
- OG007
- value
- 18
- group Id
- OG008
- value
- 3
- group Id
- OG009
- value
- 9
- group Id
- OG010
- value
- 5
- group Id
- OG011
- value
- 9
- title
- TEAEs associated with dose reduction
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 18
- group Id
- OG008
- value
- 2
- group Id
- OG009
- value
- 9
- group Id
- OG010
- value
- 4
- group Id
- OG011
- value
- 9
- title
- Drug-related TEAEs associated with dose reduction
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 6
- group Id
- OG006
- value
- 50
- group Id
- OG007
- value
- 66
- group Id
- OG008
- value
- 21
- group Id
- OG009
- value
- 33
- group Id
- OG010
- value
- 19
- group Id
- OG011
- value
- 25
- units
- Participants
- description
- Treatment-emergent adverse events were graded by Common Terminology Criteria for Adverse Events, v4.03.
- groups
- description
- Participants in Cohort 1 received an intravenous 0.8 mg/kg dose of DS-8201a (FL-DP1).
- id
- OG000
- title
- Dose Escalation: Cohort 1, 0.8 mg/kg
- description
- Participants in Cohort 2 received an intravenous 1.6 mg/kg dose of DS-8201a (FL-DP1).
- id
- OG001
- title
- Dose Escalation: Cohort 2, 1.6 mg/kg
- description
- Participants in Cohort 3 received an intravenous 3.2 mg/kg dose of DS-8201a (FL-DP1).
- id
- OG002
- title
- Dose Escalation: Cohort 3, 3.2 mg/kg
- description
- Participants in Cohort 4 received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
- id
- OG003
- title
- Dose Escalation: Cohort 4, 5.4 mg/kg
- description
- Participants in Cohort 5 received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
- id
- OG004
- title
- Dose Escalation: Cohort 5, 6.4 mg/kg
- description
- Participants in Cohort 6 received an intravenous 8.0 mg/kg dose of DS-8201a (FL-DP1).
- id
- OG005
- title
- Dose Escalation: Cohort 6, 8.0 mg/kg
- description
- Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
- id
- OG006
- title
- Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg
- description
- Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
- id
- OG007
- title
- Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg
- description
- Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
- id
- OG008
- title
- Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg
- description
- Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
- id
- OG009
- title
- Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg
- description
- Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
- id
- OG010
- title
- Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg
- description
- Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
- id
- OG011
- title
- Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety events were assessed in the Safety Analysis Set. It was prespecified in the protocol that single patients with unique tumor types would be combined into 1 group for the safety analysis. For the safety overview, TEAEs for HER2-expressing NSCLC, Colorectal, and Other Solid Tumors (excluding 1 HER2-low gastric cancer subject who received 5.4 mg/kg) were combined and reported together.
- reporting Status
- POSTED
- time Frame
- Baseline up to 28 days after the last dose of study drug, up to 3 years 5 months
- title
- Overview of Treatment-emergent Adverse Events
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice