SITE011-0107
completed

AEs

8

Serious

3

Dropout signal

–

Adverse events

8

Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-10-04 (study day 79); relationship: not assessed

mild assessed

Grade 2 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2022-10-04 (study day 79); relationship: NOT RELATED

moderate assessed

Grade 4 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-09-14 (study day 59); relationship: RELATED; serious criteria: life-threatening

severe serious assessed

Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-09-05 (study day 50); relationship: NOT RELATED

mild assessed

Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2022-08-22 (study day 36); relationship: not assessed

moderate assessed

Grade 4 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-08-20 (study day 34); relationship: NOT RELATED; serious criteria: life-threatening

severe serious assessed

Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-07-29 (study day 12); relationship: not assessed; serious criteria: hospitalization

severe serious assessed

Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2022-07-28 (study day 11); relationship: RELATED

moderate assessed

Data queries

0

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