Trial Outcomes & Findings for A Study of Talimogene Laherparepvec in Stage IIIc and Stage IV Malignant Melanoma (NCT NCT00289016)

Last Updated: 2015-12-18

Results Overview

Objective response rate is defined as the percentage of participants with an overall best response of complete response or partial response. The objective response to treatment was assessed by computed tomography (CT) scanning or other clinical measurement using modified Response Evaluation Criteria In Solid Tumors (RECIST). Responses must have been confirmed on two visits not less than 4 weeks apart. Tumor burden for a visit was calculated as the sum of the longest diameters of all tumors identified and measured up to that visit. Tumor response at each visit was derived from tumor burden, as follows: * Complete response (CR): zero tumor burden * Partial response (PR): a 30% or greater decrease in tumor burden * Progressive disease (PD): a 20% or greater increase in tumor burden * Stable disease (SD): none of the above (a \< 30% decrease and \< 20% increase in tumor burden)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

50 participants

Primary outcome timeframe

From enrollment until the data cut-off date of 29 November 2008; Median duration of follow-up was 253 days

Results posted on

2015-12-18

Participant Flow

Participant milestones

Participant milestones
Measure	Talimogene Laherparepvec Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque forming units (PFU)/mL injected into 1 or more tumors with maximum total volume of 4 mL (up to 2 mL per tumor). Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks for up to 15 weeks. After the initial 8 doses, if indications of biological activity were observed, treatment could continue for up to 16 additional doses.
Overall Study STARTED	50
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	37

Reasons for withdrawal

Reasons for withdrawal
Measure	Talimogene Laherparepvec Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque forming units (PFU)/mL injected into 1 or more tumors with maximum total volume of 4 mL (up to 2 mL per tumor). Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks for up to 15 weeks. After the initial 8 doses, if indications of biological activity were observed, treatment could continue for up to 16 additional doses.
Overall Study Disease Progression	29
Overall Study Death	2
Overall Study Unrelated Medical Condition or Accident	2
Overall Study Withdrawal by Subject	2
Overall Study Adverse Event	1
Overall Study Other	1

Baseline Characteristics

A Study of Talimogene Laherparepvec in Stage IIIc and Stage IV Malignant Melanoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Talimogene Laherparepvec n=50 Participants Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque forming units (PFU)/mL injected into 1 or more tumors with maximum total volume of 4 mL (up to 2 mL per tumor). Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks for up to 15 weeks. After the initial 8 doses, if indications of biological activity were observed, treatment could continue for up to 16 additional doses.
Age, Continuous	63 years STANDARD_DEVIATION 15.2 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants
Race/Ethnicity, Customized White	48 participants n=5 Participants
Race/Ethnicity, Customized Asian	1 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	1 participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance 0 (Fully active)	31 participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance 1 (Restrictive but ambulatory)	19 participants n=5 Participants
Tumor, Node, Metastasis (TNM) Disease Stage Stage IIIC	13 participants n=5 Participants
Tumor, Node, Metastasis (TNM) Disease Stage Stage IVM1a	13 participants n=5 Participants
Tumor, Node, Metastasis (TNM) Disease Stage Stage IVM1b	5 participants n=5 Participants
Tumor, Node, Metastasis (TNM) Disease Stage Stage IVM1c	19 participants n=5 Participants

PRIMARY outcome

Timeframe: From enrollment until the data cut-off date of 29 November 2008; Median duration of follow-up was 253 days

Population: Intent-to-treat (ITT) population (all participants who received at least 1 dose of talimogene laherparepvec)

Outcome measures

Outcome measures
Measure	Talimogene Laherparepvec n=50 Participants Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque forming units (PFU)/mL injected into 1 or more tumors with maximum total volume of 4 mL (up to 2 mL per tumor). Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks for up to 15 weeks. After the initial 8 doses, if indications of biological activity were observed, treatment could continue for up to 16 additional doses.
Objective Tumor Response Rate	28 percentage of participants

SECONDARY outcome

Timeframe: From enrollment until the data cut-off date of 29 November 2008; Median duration of follow-up was 253 days

Population: ITT population

Overall survival (OS) was calculated from the date of the first talimogene laherparepvec dose to the date of death. Median OS was estimated using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Talimogene Laherparepvec n=50 Participants Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque forming units (PFU)/mL injected into 1 or more tumors with maximum total volume of 4 mL (up to 2 mL per tumor). Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks for up to 15 weeks. After the initial 8 doses, if indications of biological activity were observed, treatment could continue for up to 16 additional doses.
Overall Survival	448.0 days Interval 38.0 to 1174.0

SECONDARY outcome

Timeframe: From enrollment until the data cut-off date of 29 November 2008; Median duration of follow-up was 253 days.

Population: ITT population

Time to progression was calculated from the date of the first talimogene laherparepvec dose to the first date of documented progressive disease (via clinical symptom or tumor burden assessment) that was not followed by a later response of CR, PR, or stable disease. Median time to progression was calculated using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Talimogene Laherparepvec n=50 Participants Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque forming units (PFU)/mL injected into 1 or more tumors with maximum total volume of 4 mL (up to 2 mL per tumor). Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks for up to 15 weeks. After the initial 8 doses, if indications of biological activity were observed, treatment could continue for up to 16 additional doses.
Time to Progression	146.0 days Interval 15.0 to 607.0

SECONDARY outcome

Timeframe: From enrollment until the data cut-off date of 29 November 2008; Median duration of follow-up was 253 days.

Population: ITT population with an objective response (PR or CR)

Time to response was calculated from the date of the first talimogene laherparepvec dose to the initial date of the participant's last response interval.

Outcome measures

Outcome measures
Measure	Talimogene Laherparepvec n=14 Participants Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque forming units (PFU)/mL injected into 1 or more tumors with maximum total volume of 4 mL (up to 2 mL per tumor). Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks for up to 15 weeks. After the initial 8 doses, if indications of biological activity were observed, treatment could continue for up to 16 additional doses.
Time to Longest Continuous Response	100 days Interval 72.0 to 288.0

SECONDARY outcome

Timeframe: From enrollment until the data cut-off date of 29 November 2008; Median duration of follow-up was 253 days.

Population: ITT population with an objective response (PR or CR)

Duration of response was calculated from the initial date of response (CR or PR) until the date of progressive disease (or until last follow up that was CR or PR). Participants could have multiple response periods; in this situation, the last response interval was used for the calculation of duration of response.

Outcome measures

Outcome measures
Measure	Talimogene Laherparepvec n=14 Participants Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque forming units (PFU)/mL injected into 1 or more tumors with maximum total volume of 4 mL (up to 2 mL per tumor). Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks for up to 15 weeks. After the initial 8 doses, if indications of biological activity were observed, treatment could continue for up to 16 additional doses.
Duration of Response	223 days Interval 1.0 to 519.0

SECONDARY outcome

Timeframe: From first dose of talimogene laherparepvec until 30 days after the last dose; the median (minimum, maximum) duration of treatment was 82 (1, 346) days.

Population: ITT population

The severity of an adverse event (AE) was graded according to Common Toxicity Criteria for Adverse Events (CTCAE) Version 3 (1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death). Serious adverse events include death, life-threatening events, events requiring or prolonging hospitalization, result in persistent or significant disability/incapacity, or a congenital anomaly/birth defect, or otherwise important medical events that may jeopardise the patient or require intervention to prevent one of the above outcomes.

Outcome measures

Outcome measures
Measure	Talimogene Laherparepvec n=50 Participants Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque forming units (PFU)/mL injected into 1 or more tumors with maximum total volume of 4 mL (up to 2 mL per tumor). Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks for up to 15 weeks. After the initial 8 doses, if indications of biological activity were observed, treatment could continue for up to 16 additional doses.
Number of Participants With Adverse Events Any adverse event	48 participants
Number of Participants With Adverse Events Treatment-related adverse event	39 participants
Number of Participants With Adverse Events Adverse event ≥ grade 3	23 participants
Number of Participants With Adverse Events Fatal adverse events	5 participants
Number of Participants With Adverse Events Serious adverse events	17 participants
Number of Participants With Adverse Events Discontinued study treatment due to adverse event	2 participants
Number of Participants With Adverse Events Flu-like symptoms	42 participants
Number of Participants With Adverse Events Injection site reactions	27 participants

Adverse Events

Talimogene Laherparepvec

Serious events: 17 serious events

Other events: 48 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Talimogene Laherparepvec n=50 participants at risk Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque forming units (PFU)/mL injected into 1 or more tumors with maximum total volume of 4 mL (up to 2 mL per tumor). Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks for up to 15 weeks. After the initial 8 doses, if indications of biological activity were observed, treatment could continue for up to 16 additional doses.
Blood and lymphatic system disorders Anaemia	2.0% 1/50 • The median (minimum, maximum) duration of treatment was 82 (1, 346) days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Atrioventricular block complete	2.0% 1/50 • The median (minimum, maximum) duration of treatment was 82 (1, 346) days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Gastrointestinal haemorrhage	2.0% 1/50 • The median (minimum, maximum) duration of treatment was 82 (1, 346) days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Intestinal obstruction	2.0% 1/50 • The median (minimum, maximum) duration of treatment was 82 (1, 346) days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Pancreatitis	2.0% 1/50 • The median (minimum, maximum) duration of treatment was 82 (1, 346) days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Chest pain	2.0% 1/50 • The median (minimum, maximum) duration of treatment was 82 (1, 346) days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Disease progression	14.0% 7/50 • The median (minimum, maximum) duration of treatment was 82 (1, 346) days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Pyrexia	4.0% 2/50 • The median (minimum, maximum) duration of treatment was 82 (1, 346) days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Pneumonia	2.0% 1/50 • The median (minimum, maximum) duration of treatment was 82 (1, 346) days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Head injury	2.0% 1/50 • The median (minimum, maximum) duration of treatment was 82 (1, 346) days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant pleural effusion	2.0% 1/50 • The median (minimum, maximum) duration of treatment was 82 (1, 346) days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic pain	2.0% 1/50 • The median (minimum, maximum) duration of treatment was 82 (1, 346) days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Cerebrovascular accident	2.0% 1/50 • The median (minimum, maximum) duration of treatment was 82 (1, 346) days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	2.0% 1/50 • The median (minimum, maximum) duration of treatment was 82 (1, 346) days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.0% 1/50 • The median (minimum, maximum) duration of treatment was 82 (1, 346) days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Hypertension	2.0% 1/50 • The median (minimum, maximum) duration of treatment was 82 (1, 346) days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Hypotension	2.0% 1/50 • The median (minimum, maximum) duration of treatment was 82 (1, 346) days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

Other adverse events

Other adverse events
Measure	Talimogene Laherparepvec n=50 participants at risk Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque forming units (PFU)/mL injected into 1 or more tumors with maximum total volume of 4 mL (up to 2 mL per tumor). Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks for up to 15 weeks. After the initial 8 doses, if indications of biological activity were observed, treatment could continue for up to 16 additional doses.
Blood and lymphatic system disorders Anaemia	14.0% 7/50 • The median (minimum, maximum) duration of treatment was 82 (1, 346) days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Abdominal pain	8.0% 4/50 • The median (minimum, maximum) duration of treatment was 82 (1, 346) days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Abdominal tenderness	6.0% 3/50 • The median (minimum, maximum) duration of treatment was 82 (1, 346) days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Constipation	6.0% 3/50 • The median (minimum, maximum) duration of treatment was 82 (1, 346) days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Diarrhoea	12.0% 6/50 • The median (minimum, maximum) duration of treatment was 82 (1, 346) days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Gastrooesophageal reflux disease	6.0% 3/50 • The median (minimum, maximum) duration of treatment was 82 (1, 346) days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Nausea	32.0% 16/50 • The median (minimum, maximum) duration of treatment was 82 (1, 346) days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Vomiting	22.0% 11/50 • The median (minimum, maximum) duration of treatment was 82 (1, 346) days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Asthenia	6.0% 3/50 • The median (minimum, maximum) duration of treatment was 82 (1, 346) days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Chest pain	6.0% 3/50 • The median (minimum, maximum) duration of treatment was 82 (1, 346) days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Chills	46.0% 23/50 • The median (minimum, maximum) duration of treatment was 82 (1, 346) days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Fatigue	32.0% 16/50 • The median (minimum, maximum) duration of treatment was 82 (1, 346) days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Influenza like illness	18.0% 9/50 • The median (minimum, maximum) duration of treatment was 82 (1, 346) days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Injection site reaction	6.0% 3/50 • The median (minimum, maximum) duration of treatment was 82 (1, 346) days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Malaise	6.0% 3/50 • The median (minimum, maximum) duration of treatment was 82 (1, 346) days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Oedema peripheral	6.0% 3/50 • The median (minimum, maximum) duration of treatment was 82 (1, 346) days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Pain	14.0% 7/50 • The median (minimum, maximum) duration of treatment was 82 (1, 346) days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Pyrexia	54.0% 27/50 • The median (minimum, maximum) duration of treatment was 82 (1, 346) days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Tenderness	8.0% 4/50 • The median (minimum, maximum) duration of treatment was 82 (1, 346) days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Oral herpes	6.0% 3/50 • The median (minimum, maximum) duration of treatment was 82 (1, 346) days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Blood urea increased	6.0% 3/50 • The median (minimum, maximum) duration of treatment was 82 (1, 346) days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Anorexia	10.0% 5/50 • The median (minimum, maximum) duration of treatment was 82 (1, 346) days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Decreased appetite	6.0% 3/50 • The median (minimum, maximum) duration of treatment was 82 (1, 346) days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Arthralgia	10.0% 5/50 • The median (minimum, maximum) duration of treatment was 82 (1, 346) days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Back pain	6.0% 3/50 • The median (minimum, maximum) duration of treatment was 82 (1, 346) days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Muscle spasms	6.0% 3/50 • The median (minimum, maximum) duration of treatment was 82 (1, 346) days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Myalgia	18.0% 9/50 • The median (minimum, maximum) duration of treatment was 82 (1, 346) days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Pain in extremity	14.0% 7/50 • The median (minimum, maximum) duration of treatment was 82 (1, 346) days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Dizziness	6.0% 3/50 • The median (minimum, maximum) duration of treatment was 82 (1, 346) days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Headache	20.0% 10/50 • The median (minimum, maximum) duration of treatment was 82 (1, 346) days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Anxiety	8.0% 4/50 • The median (minimum, maximum) duration of treatment was 82 (1, 346) days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Depression	14.0% 7/50 • The median (minimum, maximum) duration of treatment was 82 (1, 346) days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Insomnia	6.0% 3/50 • The median (minimum, maximum) duration of treatment was 82 (1, 346) days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Cough	8.0% 4/50 • The median (minimum, maximum) duration of treatment was 82 (1, 346) days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Dyspnoea	8.0% 4/50 • The median (minimum, maximum) duration of treatment was 82 (1, 346) days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Pleural effusion	6.0% 3/50 • The median (minimum, maximum) duration of treatment was 82 (1, 346) days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Rash	8.0% 4/50 • The median (minimum, maximum) duration of treatment was 82 (1, 346) days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Skin reaction	6.0% 3/50 • The median (minimum, maximum) duration of treatment was 82 (1, 346) days. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

Additional Information

Study Director

Amgen, Inc.

Phone: 866-572-6436

Results disclosure agreements

Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Publication restrictions are in place

Restriction type: OTHER