NCT01558921 · ADVERSE EVENTS

Adverse events

Rectal Cancer And Pre-operative Induction Therapy Followed by Dedicated Operation. The RAPIDO Trial · Source last updated 2026-05-01

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: 3 years
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
B: 5x5Gy -> CAPOX -> Surgery experimental group (arm B) M1 scheme M1 scheme: short course 5 x 5 Gy radiation scheme is followed by six cycles of combination chemotherapy (capecitabine and oxaliplatin (CAPOX)) and surgery. FOLFOX4 may be given as alternative for CAPOX	31 / 460	429 / 460	40 / 460
A: 5 Weeks Chemoradiation -> Surgery control group (arm A) standard long course chemoradiotherapy standard long course chemoradiotherapy: long course chemoradiotherapy followed by surgery. Optional adjuvant chemotherapy (CAPOX or FOLFOX) is allowed in the control group.	13 / 441	421 / 441	36 / 441

Group identifiers: EG000: B: 5x5Gy -> CAPOX -> Surgery · EG001: A: 5 Weeks Chemoradiation -> Surgery

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
31
num At Risk
460
num Events
31
group Id
EG001
num Affected
13
num At Risk
441
num Events
13
term
grade 4+5 AEs

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
429
num At Risk
460
num Events
429
group Id
EG001
num Affected
421
num At Risk
441
num Events
421
term
Grade 1-3 AEs

Complete source fields

event Groups

deaths Num Affected
40
deaths Num At Risk
460
description
experimental group (arm B) M1 scheme M1 scheme: short course 5 x 5 Gy radiation scheme is followed by six cycles of combination chemotherapy (capecitabine and oxaliplatin (CAPOX)) and surgery. FOLFOX4 may be given as alternative for CAPOX
id
EG000
other Num Affected
429
other Num At Risk
460
serious Num Affected
31
serious Num At Risk
460
title
B: 5x5Gy -> CAPOX -> Surgery
deaths Num Affected
36
deaths Num At Risk
441
description
control group (arm A) standard long course chemoradiotherapy standard long course chemoradiotherapy: long course chemoradiotherapy followed by surgery. Optional adjuvant chemotherapy (CAPOX or FOLFOX) is allowed in the control group.
id
EG001
other Num Affected
421
other Num At Risk
441
serious Num Affected
13
serious Num At Risk
441
title
A: 5 Weeks Chemoradiation -> Surgery

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
429
num At Risk
460
num Events
429
group Id
EG001
num Affected
421
num At Risk
441
num Events
421
term
Grade 1-3 AEs

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
31
num At Risk
460
num Events
31
group Id
EG001
num Affected
13
num At Risk
441
num Events
13
term
grade 4+5 AEs

time Frame

3 years

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Independent clinical review pending · Not medical advice