Trial Outcomes & Findings for Chemotherapy Before Autologous Stem Cell Transplantation +/- Rituximab in Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma (NCT NCT00078949)

NCT ID: NCT00078949

Last Updated: 2023-08-23

Results Overview

The overall response rate by arm is calculated as total number of responders (CR + CRu + PR) / (all patients in the ITT analysis population).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 849 participants
• Primary outcome timeframe: After 2 cycle of treatment
• Results posted on: 2023-08-23

Participant Flow

619 patients in the first randomization. Only a selected subset of patient (N = 230) were randomized in period 2 of this study. Total sample size N = 849

Participant milestones

Measure	Salvage GDP Patients receive cisplatin IV over 60 minutes on day 1, dexamethasone IV or orally on days 1-4, and gemcitabine IV over 30 minutes on days 1 and 8. cisplatin: Given IV dexamethasone: Given IV gemcitabine hydrochloride: Given IV	Salvage DHAP Patients receive cisplatin IV over 24 hours on day 1, dexamethasone as in arm I, and cytarabine IV over 3 hours every 12 hours for a total of 2 doses on day 2. cisplatin: Given IV cytarabine: Given IV dexamethasone: Given IV	Maintenance Beginning on day 28 posttransplantation, patients receive rituximab IV once every 2 months for 6 doses (a total of 12 months) in the absence of disease progression or unacceptable toxicity. rituximab: Given IV	Observation Patients undergo observation only.
Overall Study STARTED	310	309	115	115
Overall Study COMPLETED	306	304	112	112
Overall Study NOT COMPLETED	4	5	3	3

Reasons for withdrawal

Measure	Salvage GDP Patients receive cisplatin IV over 60 minutes on day 1, dexamethasone IV or orally on days 1-4, and gemcitabine IV over 30 minutes on days 1 and 8. cisplatin: Given IV dexamethasone: Given IV gemcitabine hydrochloride: Given IV	Salvage DHAP Patients receive cisplatin IV over 24 hours on day 1, dexamethasone as in arm I, and cytarabine IV over 3 hours every 12 hours for a total of 2 doses on day 2. cisplatin: Given IV cytarabine: Given IV dexamethasone: Given IV	Maintenance Beginning on day 28 posttransplantation, patients receive rituximab IV once every 2 months for 6 doses (a total of 12 months) in the absence of disease progression or unacceptable toxicity. rituximab: Given IV	Observation Patients undergo observation only.
Overall Study No treated	4	5	3	3

Baseline Characteristics

Chemotherapy Before Autologous Stem Cell Transplantation +/- Rituximab in Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma

Baseline characteristics by cohort

Measure	Salvage GDP n=310 Participants Patients receive cisplatin IV over 60 minutes on day 1, dexamethasone IV or orally on days 1-4, and gemcitabine IV over 30 minutes on days 1 and 8. cisplatin: Given IV dexamethasone: Given IV gemcitabine hydrochloride: Given IV	Salvage DHAP n=309 Participants Patients receive cisplatin IV over 24 hours on day 1, dexamethasone as in arm I, and cytarabine IV over 3 hours every 12 hours for a total of 2 doses on day 2. cisplatin: Given IV cytarabine: Given IV dexamethasone: Given IV	Maintenance n=115 Participants Beginning on day 28 posttransplantation, patients receive rituximab IV once every 2 months for 6 doses (a total of 12 months) in the absence of disease progression or unacceptable toxicity. rituximab: Given IV	Observation n=115 Participants Patients undergo observation only.	Total n=849 Participants Total of all reporting groups
Age, Continuous	55 years n=5 Participants	55 years n=7 Participants	54 years n=5 Participants	55 years n=4 Participants	55 years n=21 Participants
Sex: Female, Male Female	122 Participants n=5 Participants	118 Participants n=7 Participants	44 Participants n=5 Participants	48 Participants n=4 Participants	332 Participants n=21 Participants
Sex: Female, Male Male	188 Participants n=5 Participants	191 Participants n=7 Participants	71 Participants n=5 Participants	67 Participants n=4 Participants	517 Participants n=21 Participants

PRIMARY outcome

Timeframe: After 2 cycle of treatment

Population: ITT population

The overall response rate by arm is calculated as total number of responders (CR + CRu + PR) / (all patients in the ITT analysis population).

Outcome measures

Measure	Salvage GDP n=310 Participants Patients receive cisplatin IV over 60 minutes on day 1, dexamethasone IV or orally on days 1-4, and gemcitabine IV over 30 minutes on days 1 and 8. cisplatin: Given IV dexamethasone: Given IV gemcitabine hydrochloride: Given IV	Salvage DHAP n=309 Participants Patients receive cisplatin IV over 24 hours on day 1, dexamethasone as in arm I, and cytarabine IV over 3 hours every 12 hours for a total of 2 doses on day 2. cisplatin: Given IV cytarabine: Given IV dexamethasone: Given IV	Maintenance Beginning on day 28 posttransplantation, patients receive rituximab IV once every 2 months for 6 doses (a total of 12 months) in the absence of disease progression or unacceptable toxicity. rituximab: Given IV	Observation Patients undergo observation only.
Response Rate of Patients After 2 Courses of Chemotherapy	45.2 percentage of response	44.0 percentage of response	—	—

PRIMARY outcome

Timeframe: During period 1 (salvage chemotherapy)

Transplantation rate is defined as the number of patients who respond sufficiently to protocol salvage chemotherapy to be planned for transplantation minus those who do not meet the endpoint of successful transplantation, divided by the number of all randomized patients

Outcome measures

Measure	Salvage GDP n=310 Participants Patients receive cisplatin IV over 60 minutes on day 1, dexamethasone IV or orally on days 1-4, and gemcitabine IV over 30 minutes on days 1 and 8. cisplatin: Given IV dexamethasone: Given IV gemcitabine hydrochloride: Given IV	Salvage DHAP n=309 Participants Patients receive cisplatin IV over 24 hours on day 1, dexamethasone as in arm I, and cytarabine IV over 3 hours every 12 hours for a total of 2 doses on day 2. cisplatin: Given IV cytarabine: Given IV dexamethasone: Given IV	Maintenance Beginning on day 28 posttransplantation, patients receive rituximab IV once every 2 months for 6 doses (a total of 12 months) in the absence of disease progression or unacceptable toxicity. rituximab: Given IV	Observation Patients undergo observation only.
Transplantation Rate of Patients After 2 Courses of Chemotherapy	51.0 percentage of transplantation	48.9 percentage of transplantation	—	—

PRIMARY outcome

Timeframe: during the period 2 (up to10 years)

Population: ITT population

Number of patients who develop EFS event during maintenance randomization (period 2)

Outcome measures

Measure	Salvage GDP n=115 Participants Patients receive cisplatin IV over 60 minutes on day 1, dexamethasone IV or orally on days 1-4, and gemcitabine IV over 30 minutes on days 1 and 8. cisplatin: Given IV dexamethasone: Given IV gemcitabine hydrochloride: Given IV	Salvage DHAP n=115 Participants Patients receive cisplatin IV over 24 hours on day 1, dexamethasone as in arm I, and cytarabine IV over 3 hours every 12 hours for a total of 2 doses on day 2. cisplatin: Given IV cytarabine: Given IV dexamethasone: Given IV	Maintenance Beginning on day 28 posttransplantation, patients receive rituximab IV once every 2 months for 6 doses (a total of 12 months) in the absence of disease progression or unacceptable toxicity. rituximab: Given IV	Observation Patients undergo observation only.
Event-free Survival of Patients on Maintenance Randomization (Period 2)	53 participants	65 participants	—	—

SECONDARY outcome

Timeframe: 48 months

Population: All patients who received the protocol treatment.

Number of patients affected by adverse events graded according to CTC Version 2.0. See adverse event (others) for details.

Outcome measures

Measure	Salvage GDP n=306 Participants Patients receive cisplatin IV over 60 minutes on day 1, dexamethasone IV or orally on days 1-4, and gemcitabine IV over 30 minutes on days 1 and 8. cisplatin: Given IV dexamethasone: Given IV gemcitabine hydrochloride: Given IV	Salvage DHAP n=304 Participants Patients receive cisplatin IV over 24 hours on day 1, dexamethasone as in arm I, and cytarabine IV over 3 hours every 12 hours for a total of 2 doses on day 2. cisplatin: Given IV cytarabine: Given IV dexamethasone: Given IV	Maintenance n=112 Participants Beginning on day 28 posttransplantation, patients receive rituximab IV once every 2 months for 6 doses (a total of 12 months) in the absence of disease progression or unacceptable toxicity. rituximab: Given IV	Observation n=112 Participants Patients undergo observation only.
Toxic Effect	36 Participants	26 Participants	16 Participants	8 Participants

Adverse Events

Salvage GDP

Serious events: 36 serious events

Other events: 287 other events

Deaths: 177 deaths

Salvage DHAP

Serious events: 26 serious events

Other events: 293 other events

Deaths: 181 deaths

Maintenance

Serious events: 16 serious events

Other events: 98 other events

Deaths: 39 deaths

Observation

Serious events: 8 serious events

Other events: 90 other events

Deaths: 42 deaths

Serious adverse events

Measure	Salvage GDP n=306 participants at risk Patients receive cisplatin IV over 60 minutes on day 1, dexamethasone IV or orally on days 1-4, and gemcitabine IV over 30 minutes on days 1 and 8. cisplatin: Given IV dexamethasone: Given IV gemcitabine hydrochloride: Given IV	Salvage DHAP n=304 participants at risk Patients receive cisplatin IV over 24 hours on day 1, dexamethasone as in arm I, and cytarabine IV over 3 hours every 12 hours for a total of 2 doses on day 2. cisplatin: Given IV cytarabine: Given IV dexamethasone: Given IV	Maintenance n=112 participants at risk Beginning on day 28 posttransplantation, patients receive rituximab IV once every 2 months for 6 doses (a total of 12 months) in the absence of disease progression or unacceptable toxicity. rituximab: Given IV	Observation n=112 participants at risk Patients undergo observation only.
Blood and lymphatic system disorders Hemoglobin	0.33% 1/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Blood and lymphatic system disorders DIC	0.33% 1/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Blood and lymphatic system disorders Febrile neutropenia	0.98% 3/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	3.6% 11/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	2.7% 3/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.89% 1/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Cardiac disorders Edema	0.33% 1/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Cardiac disorders Ischemia/infarction	0.33% 1/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.33% 1/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Cardiac disorders Pericardial effusion	0.00% 0/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.33% 1/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Cardiac disorders Sinus tachycardia	0.00% 0/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.33% 1/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Gastrointestinal disorders Colitis	0.00% 0/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.66% 2/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.89% 1/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.89% 1/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Gastrointestinal disorders Constipation	0.00% 0/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.89% 1/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Gastrointestinal disorders Diarrhea	0.65% 2/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.66% 2/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	2.7% 3/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Gastrointestinal disorders Dysphagia	0.33% 1/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Gastrointestinal disorders Nausea	1.3% 4/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	1.8% 2/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.89% 1/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Gastrointestinal disorders Duodenal ulcer	0.33% 1/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Gastrointestinal disorders Gastric ulcer	0.33% 1/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.89% 1/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Gastrointestinal disorders Vomiting	0.65% 2/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.66% 2/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	1.8% 2/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Gastrointestinal disorders Melena/GI bleeding	0.33% 1/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Gastrointestinal disorders Rectal bleeding	0.33% 1/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.33% 1/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Gastrointestinal disorders Hematemesis	0.33% 1/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Gastrointestinal disorders Abdominal pain	1.3% 4/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.66% 2/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.89% 1/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.89% 1/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
General disorders Fatigue	0.00% 0/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.33% 1/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
General disorders Pain-Other	0.65% 2/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.89% 1/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.89% 1/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Immune system disorders Other	0.33% 1/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Immune system disorders Fever	0.98% 3/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.99% 3/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	1.8% 2/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Infections and infestations Wound-infectious	0.33% 1/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Investigations Granulocytes	0.65% 2/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.89% 1/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Investigations Lymphopenia	0.33% 1/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Investigations Platelets	0.00% 0/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.33% 1/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Investigations Leukocytes (total WBC)	0.33% 1/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.33% 1/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Investigations Cardiac troponin T	0.00% 0/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.33% 1/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Investigations Creatinine	0.33% 1/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.66% 2/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.89% 1/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Investigations SGPT (ALT)	0.33% 1/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Investigations SGOT (AST)	0.33% 1/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Investigations Bilirubin	0.33% 1/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Investigations Weight loss	0.33% 1/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.89% 1/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Metabolism and nutrition disorders Dehydration	0.33% 1/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.33% 1/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.89% 1/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Secondary Malignancy	0.65% 2/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	1.3% 4/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	2.7% 3/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	2.7% 3/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Nervous system disorders Hemorrhage/bleeding	0.33% 1/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Nervous system disorders Speech impairment	0.65% 2/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Nervous system disorders Neuropathy-sensory	0.33% 1/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Nervous system disorders Syncope	0.33% 1/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.89% 1/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Nervous system disorders Headache	0.33% 1/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.89% 1/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Psychiatric disorders Confusion	0.00% 0/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.33% 1/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Renal and urinary disorders Renal failure	0.00% 0/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.33% 1/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Renal and urinary disorders Dysuria	0.33% 1/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Renal and urinary disorders Hematuria	0.65% 2/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Respiratory, thoracic and mediastinal disorders ARDS	0.00% 0/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.33% 1/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.33% 1/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.33% 1/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Respiratory, thoracic and mediastinal disorders Dyspnea	0.65% 2/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.99% 3/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	1.8% 2/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Vascular disorders Hypertension	0.00% 0/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.33% 1/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Vascular disorders Hypotension	0.33% 1/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.33% 1/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.89% 1/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Vascular disorders Thrombosis/embolism	1.6% 5/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.66% 2/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	2.7% 3/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.89% 1/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants

Other adverse events

Measure	Salvage GDP n=306 participants at risk Patients receive cisplatin IV over 60 minutes on day 1, dexamethasone IV or orally on days 1-4, and gemcitabine IV over 30 minutes on days 1 and 8. cisplatin: Given IV dexamethasone: Given IV gemcitabine hydrochloride: Given IV	Salvage DHAP n=304 participants at risk Patients receive cisplatin IV over 24 hours on day 1, dexamethasone as in arm I, and cytarabine IV over 3 hours every 12 hours for a total of 2 doses on day 2. cisplatin: Given IV cytarabine: Given IV dexamethasone: Given IV	Maintenance n=112 participants at risk Beginning on day 28 posttransplantation, patients receive rituximab IV once every 2 months for 6 doses (a total of 12 months) in the absence of disease progression or unacceptable toxicity. rituximab: Given IV	Observation n=112 participants at risk Patients undergo observation only.
Blood and lymphatic system disorders Febrile neutropenia	9.2% 28/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	23.4% 71/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	8.9% 10/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	2.7% 3/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Cardiac disorders Edema	12.7% 39/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	21.1% 64/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	7.1% 8/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	8.0% 9/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Ear and labyrinth disorders Inner ear/hearing	16.3% 50/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	25.0% 76/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	12.5% 14/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	10.7% 12/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Eye disorders Blurred vision	6.9% 21/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	4.9% 15/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	4.5% 5/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	2.7% 3/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Gastrointestinal disorders Constipation	43.5% 133/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	37.2% 113/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	8.9% 10/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	12.5% 14/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Gastrointestinal disorders Diarrhea	20.9% 64/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	28.0% 85/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	17.0% 19/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	9.8% 11/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Gastrointestinal disorders Dysphagia	5.6% 17/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	5.6% 17/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	10.7% 12/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	2.7% 3/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Gastrointestinal disorders Dyspepsia/heartburn	19.3% 59/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	16.8% 51/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	15.2% 17/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	8.9% 10/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Gastrointestinal disorders Nausea	56.2% 172/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	72.7% 221/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	19.6% 22/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	12.5% 14/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Gastrointestinal disorders Stomatitis	19.9% 61/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	23.0% 70/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	6.2% 7/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	1.8% 2/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Gastrointestinal disorders Vomiting	31.0% 95/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	49.7% 151/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	16.1% 18/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	7.1% 8/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Gastrointestinal disorders Other	1.3% 4/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	2.0% 6/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	7.1% 8/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Gastrointestinal disorders Abdominal pain	21.2% 65/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	15.5% 47/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	19.6% 22/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	12.5% 14/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
General disorders Fatigue	73.5% 225/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	66.1% 201/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	58.0% 65/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	52.7% 59/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
General disorders Rigors, chills	3.3% 10/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	6.9% 21/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	5.4% 6/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	4.5% 5/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
General disorders Chest pain	6.2% 19/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	8.9% 27/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	4.5% 5/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	6.2% 7/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
General disorders Pain-Other	6.9% 21/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	7.6% 23/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	8.9% 10/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	3.6% 4/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Immune system disorders Fever	14.7% 45/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	24.3% 74/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	12.5% 14/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	10.7% 12/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Infections and infestations Infection w/o neutropen	20.9% 64/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	19.1% 58/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	44.6% 50/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	34.8% 39/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Investigations Weight loss	5.9% 18/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	4.9% 15/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	10.7% 12/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	6.2% 7/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Metabolism and nutrition disorders Anorexia	25.2% 77/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	30.9% 94/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	15.2% 17/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	14.3% 16/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Metabolism and nutrition disorders Dehydration	5.6% 17/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	7.2% 22/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	2.7% 3/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.89% 1/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Metabolism and nutrition disorders Hypomagnesemia	2.0% 6/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	5.9% 18/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	2.7% 3/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	1.8% 2/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Musculoskeletal and connective tissue disorders Muscle weakness	7.5% 23/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	6.6% 20/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	5.4% 6/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	8.0% 9/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Musculoskeletal and connective tissue disorders Arthralgia	9.2% 28/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	4.9% 15/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	17.9% 20/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	15.2% 17/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Musculoskeletal and connective tissue disorders Myalgia	16.0% 49/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	13.8% 42/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	22.3% 25/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	21.4% 24/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Musculoskeletal and connective tissue disorders Bone pain	10.8% 33/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	10.5% 32/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	15.2% 17/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	15.2% 17/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	15.0% 46/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	13.5% 41/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	5.4% 6/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	1.8% 2/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Nervous system disorders Taste disturbance	9.2% 28/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	14.1% 43/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	8.9% 10/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	9.8% 11/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Nervous system disorders Dizziness	12.7% 39/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	10.9% 33/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	10.7% 12/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	4.5% 5/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Nervous system disorders Neuropathy-motor	9.8% 30/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	4.3% 13/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	4.5% 5/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	2.7% 3/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Nervous system disorders Neuropathy-sensory	34.6% 106/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	24.3% 74/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	22.3% 25/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	25.0% 28/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Nervous system disorders Syncope	2.3% 7/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	5.3% 16/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.89% 1/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Nervous system disorders Headache	19.3% 59/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	23.7% 72/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	8.9% 10/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	5.4% 6/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Nervous system disorders Neuropathic pain	2.3% 7/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	3.0% 9/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	8.0% 9/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	7.1% 8/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Psychiatric disorders Anxiety	13.1% 40/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	9.9% 30/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	8.9% 10/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	7.1% 8/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Psychiatric disorders Insomnia	19.9% 61/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	17.8% 54/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	11.6% 13/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	8.9% 10/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Psychiatric disorders Depression	6.5% 20/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	4.3% 13/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	6.2% 7/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	6.2% 7/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	2.6% 8/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	3.0% 9/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	8.9% 10/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	7.1% 8/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Respiratory, thoracic and mediastinal disorders Epistaxis	6.5% 20/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	5.3% 16/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Respiratory, thoracic and mediastinal disorders Cough	18.0% 55/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	20.1% 61/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	33.9% 38/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	17.0% 19/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Respiratory, thoracic and mediastinal disorders Hiccoughs	5.9% 18/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	5.6% 17/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.00% 0/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Respiratory, thoracic and mediastinal disorders Dyspnea	21.2% 65/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	22.7% 69/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	17.0% 19/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	21.4% 24/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Skin and subcutaneous tissue disorders Sweating	16.7% 51/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	10.9% 33/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	11.6% 13/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	10.7% 12/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Skin and subcutaneous tissue disorders Alopecia	10.1% 31/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	13.8% 42/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	11.6% 13/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	8.9% 10/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Skin and subcutaneous tissue disorders Dry skin	0.98% 3/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	4.6% 14/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	6.2% 7/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	4.5% 5/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Skin and subcutaneous tissue disorders Rash/desquamation	19.9% 61/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	12.5% 38/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	8.9% 10/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	13.4% 15/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Skin and subcutaneous tissue disorders Other	2.3% 7/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	2.0% 6/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	5.4% 6/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	3.6% 4/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Vascular disorders Hypotension	4.6% 14/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	8.2% 25/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	3.6% 4/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	0.89% 1/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants
Vascular disorders Thrombosis/embolism	7.8% 24/306 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	7.9% 24/304 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	3.6% 4/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants	2.7% 3/112 • 8.5 year Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants

Additional Information

Seninor Biostatistician for LY12

NCIC

Phone: 613-533-6000

Email: bechen@ctg.queensu.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place